Rotator Cuff TearPhase 4NCT03551509
LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair
A Phase 4 study testing ArthroFLEX ECM scaffold graft and Alternative Treatment Group in people with Rotator Cuff Tear, run by Gregory Gilot at 1 site in United States.
Trial summary
This trial is to evaluate the effectiveness of the ArthroFLEX® ECM scaffold graph as an augment in rotator cuff repair surgery to reduce the failure rate of rotator cuff repairs for large and massive rotator cuff tears. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- ArthroFLEX ECM scaffold graft and Alternative Treatment Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a large (2.5-5 cm) to massive (>5 cm) rotator cuff tear who will be undergoing open or arthroscopic repair. The cuff tear size will be determined on either pre-operative magnetic resonance imaging (MRI), or ultrasound (US), or intra-operative measurements, or computerized tomography (CT).
- Patients who are willing and able to provide written informed consent for their involvement in the study.
- Patients who meet criteria for RCR surgery
- Patients older than 18 years of age
Who cannot join
- Those with a known sensitivity to materials of porcine origin.
- Patients with addiction to illegal drugs, solvents or alcohol who are actively using or have previously attempted and failed a treatment program.
- Patients with bacteremia, a systemic infection, or infection of the surgical site.
- All those who are prisoners.
- Patients who are pregnant or nursing.
- All those with a condition that may limit a patient's ability to finalize the study or that may cause an undue risk to the patient's health and well-being.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracellular Matrix Scaffold Graft Augmentation in Rotator Cuff Repair: a Prospective, Randomized, Controlled Trial
This trial is to evaluate the effectiveness of the ArthroFLEX® ECM scaffold graph as an augment in rotator cuff repair surgery to reduce the failure rate of rotator cuff repairs for large and massive rotator cuff tears.
Read the detailed description
This is a prospective, randomized, controlled, multi-center clinical trial to evaluate the effectiveness of an ECM scaffold graft to augment repair of a large/massive rotator cuff tear. The study will involve 70 patients. 35 patients will be randomly assigned to each arm of the study.
Despite advances in surgical technology, repairs of large (3-5 cm) and massive (>5 cm) rotator cuff tears (RCT) fail between 20%-90% of the time [1]. Due to their size and increased structural involvement, large or massive RCT present a substantial challenge to orthopaedic surgeons. [16] The repairs tend to fail at the suture-tendon junction, which is due to several factors, including tension at the repair and quality of the tendon [1-2,5]. Full thickness tears are uncommon in younger patients, especially those less than forty years old and are usually traumatic in etiology. Younger patients also typically fair better following arthroscopic rotator cuff repair with fewer failures and more successful return to pre-injury level of function [16]. One strategy to augment repair of large to massive rotator cuff tears has been the development of biological scaffold materials, which are composed of extracellular matrix (ECM). The ECM composing the scaffolds are made from a number of tissues, including, but not limited to, small intestinal submucosa (SIS), dermis, and pericardium [3]. Studies to date include both prospective and retrospective in animal and human models, and include Restore, a porcine-derived SIS by DePuy Orthopaedics, GraftJacket, a human-derived, non-cross-linked dermis graft by Wright Medical Technology, and Zimmer Collagen Repair, a cross-linked porcine derived dermal graft made by Zimmer. Restore studies have shown no benefit and some even an increase in repair failure with recommendations not to use to augment repair. GraftJacket studies have shown a reduction in graft failure; however, several of the Restore and GraftJacket studies are limited by a lack of a control cohort. The Zimmer graft studies have conflicting results with both an improvement and no improvement in failure rates of repair. The prior studies listed are all in vivo; however, the majority are not randomized trials and thus do not have a control with which to compare data. In addition, some trials include open repairs. A lack of prospective, randomized, controlled, in vivo trials exist that evaluate the ability of the ECM scaffold graft augmentation in large to massive arthroscopic rotator cuff repairs to decrease the failure rate.
The purpose of this study is to evaluate the efficacy of using the Arthroflex (A-FLEX) graft to augment large to massive arthroscopic rotator cuff repairs in vivo and decrease repair failures in a prospective, randomized, controlled trial. By undergoing serial US examinations at follow-ups, we also intend to evaluate when during the postoperative period the failure of the repair occurs.
- Conditions
- Rotator Cuff Tear
- Being tested
- ArthroFLEX ECM scaffold graft, Control, Alternative Treatment Group
- Keywords
- Rotator Cuff Tear, Large Rotator Cuff Tear, Massive Rotator Cuff Tear, ECM, Extracellular Matrix, ArthroFLEX
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroFLEX ECM scaffold graftProcedure or surgery
Also called Surgery with ECM graft
In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.
ControlProcedure or surgery
Also called Surgery without ECM graft
This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.
Alternative Treatment GroupBiological
Also called Repair cannot be accomplished
Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
| Study group | Role | What they receive |
|---|---|---|
| Control Treatment Group | Active comparator | Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Receives: Procedure: Control |
| Treatment Group | Active comparator | Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. Receives: Procedure: ArthroFLEX ECM scaffold graft |
| Alternative Treatment Group | Other | Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Receives: Biological: Alternative Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon Healing
Success as defined by tendon healing after rotator cuff repair, as indicated based on MRI
Measured: As assessed 1 year postoperatively.
Comparison of Healing by MRI vs US
Comparison of tendon healing will be assessed using US imaging modalities versus MRI (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Measured: As assessed 1 year postoperatively.
Progress of Tendon Healing
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Measured: As assessed at 6 weeks postoperatively.
Progress of Tendon Healing
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Measured: As assessed at 3 months postoperatively.
Progress of Tendon Healing
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Measured: As assessed at 6 months postoperatively.
Progress of Tendon Healing
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Measured: As assessed at 9 months postoperatively.
Secondary outcomes (42)
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: Preoperative
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 6 weeks after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 3 months after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 6 months after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 9 months after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 1 year after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.
Measured: Preoperative
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.
Measured: 6 weeks after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.
Measured: 3 months after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.
Measured: 6 months after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.
Measured: 9 months after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.
Measured: 1 year after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.
Measured: Preoperative
Patient Outcomes: Measurement of Shoulder Activity Level
This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.
Measured: 6 weeks after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.
Measured: 3 months after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.
Measured: 6 months after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.
Measured: 9 months after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.
Measured: 1 year after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: Preoperative
Patient Outcomes: Subjective Shoulder Value (SSV)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 6 weeks after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 3 months after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 6 months after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 9 months after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 1 year after surgery
Patient Outcomes: Constant Score (CS)
C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.
Measured: Preoperative
Patient Outcomes: Constant Score (CS)
C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.
Measured: 6 weeks after surgery
Patient Outcomes: Constant Score (CS)
C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.
Measured: 3 months after surgery
Patient Outcomes: Constant Score (CS)
C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.
Measured: 6 months after surgery
Patient Outcomes: Constant Score (CS)
C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.
Measured: 9 months after surgery
Patient Outcomes: Constant Score (CS)
C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.
Measured: 1 year after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: Preoperative
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 6 weeks after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 3 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 6 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 9 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 1 year after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: Preoperative
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 6 weeks after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 3 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 6 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 9 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Why it stopped: Sponsor terminated early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gregory Gilot
- Sponsor type
- University, hospital or other
- Collaborators
- LifeNet Health, The Cleveland Clinic
- Responsible party
- Sponsor-investigator, Gregory Gilot, The Cleveland Clinic
- Investigators
- Gregory J Gilot, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551509
- Sponsor's protocol ID
- FLA 18-008
- Status last verified
- Jun 2025
- First submitted
- 15 May 2018
- Last updated
- 19 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Derwin KA, Badylak SF, Steinmann SP, Iannotti JP. Extracellular matrix scaffold devices for rotator cuff repair. J Shoulder Elbow Surg. 2010 Apr;19(3):467-76. doi: 10.1016/j.jse.2009.10.020. Epub 2010 Feb 26.
PubMed 20189415Schlegel TF, Hawkins RJ, Lewis CW, Motta T, Turner AS. The effects of augmentation with Swine small intestine submucosa on tendon healing under tension: histologic and mechanical evaluations in sheep. Am J Sports Med. 2006 Feb;34(2):275-80. doi: 10.1177/0363546505279912. Epub 2005 Oct 6.
PubMed 16210577Badylak SF, Freytes DO, Gilbert TW. Extracellular matrix as a biological scaffold material: Structure and function. Acta Biomater. 2009 Jan;5(1):1-13. doi: 10.1016/j.actbio.2008.09.013. Epub 2008 Oct 2.
PubMed 18938117Sclamberg SG, Tibone JE, Itamura JM, Kasraeian S. Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced with porcine small intestinal submucosa. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):538-41. doi: 10.1016/j.jse.2004.03.005.
PubMed 15383811Iannotti JP, Codsi MJ, Kwon YW, Derwin K, Ciccone J, Brems JJ. Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears. A randomized, controlled trial. J Bone Joint Surg Am. 2006 Jun;88(6):1238-44. doi: 10.2106/JBJS.E.00524.
PubMed 16757756Walton JR, Bowman NK, Khatib Y, Linklater J, Murrell GA. Restore orthobiologic implant: not recommended for augmentation of rotator cuff repairs. J Bone Joint Surg Am. 2007 Apr;89(4):786-91. doi: 10.2106/JBJS.F.00315.
PubMed 17403801Zheng MH, Chen J, Kirilak Y, Willers C, Xu J, Wood D. Porcine small intestine submucosa (SIS) is not an acellular collagenous matrix and contains porcine DNA: possible implications in human implantation. J Biomed Mater Res B Appl Biomater. 2005 Apr;73(1):61-7. doi: 10.1002/jbm.b.30170.
PubMed 15736287Bond JL, Dopirak RM, Higgins J, Burns J, Snyder SJ. Arthroscopic replacement of massive, irreparable rotator cuff tears using a GraftJacket allograft: technique and preliminary results. Arthroscopy. 2008 Apr;24(4):403-409.e1. doi: 10.1016/j.arthro.2007.07.033.
PubMed 18375271Badhe SP, Lawrence TM, Smith FD, Lunn PG. An assessment of porcine dermal xenograft as an augmentation graft in the treatment of extensive rotator cuff tears. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):35S-39S. doi: 10.1016/j.jse.2007.08.005.
PubMed 18201655Soler JA, Gidwani S, Curtis MJ. Early complications from the use of porcine dermal collagen implants (Permacol) as bridging constructs in the repair of massive rotator cuff tears. A report of 4 cases. Acta Orthop Belg. 2007 Aug;73(4):432-6.
PubMed 17939470Brophy RH, Beauvais RL, Jones EC, Cordasco FA, Marx RG. Measurement of shoulder activity level. Clin Orthop Relat Res. 2005 Oct;439:101-8. doi: 10.1097/01.blo.0000173255.85016.1f.
PubMed 16205147Parnes N, Bartoszewski NR, Defranco MJ. Arthroscopic Repair of Full-Thickness Rotator Cuff Tears in Active Patients Younger Than 40 Years: 2- to 5-Year Clinical Outcomes. Orthopedics. 2018 Jan 1;41(1):e52-e57. doi: 10.3928/01477447-20171114-02. Epub 2017 Nov 21.
PubMed 29156071Chung SW, Kim JY, Kim MH, Kim SH, Oh JH. Arthroscopic repair of massive rotator cuff tears: outcome and analysis of factors associated with healing failure or poor postoperative function. Am J Sports Med. 2013 Jul;41(7):1674-83. doi: 10.1177/0363546513485719. Epub 2013 Apr 30.
PubMed 23631883Greenspoon JA, Petri M, Warth RJ, Millett PJ. Massive rotator cuff tears: pathomechanics, current treatment options, and clinical outcomes. J Shoulder Elbow Surg. 2015 Sep;24(9):1493-505. doi: 10.1016/j.jse.2015.04.005. Epub 2015 Jun 28.
PubMed 26129871
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Matrix Scaffold Graft Augmentation in Rotator Cuff Repair: a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03551509
- Acronym / sponsor ID
- FLA 18-008
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff Tear, Large Rotator Cuff Tear, Massive Rotator Cuff Tear, ECM, Extracellular Matrix, ArthroFLEX
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated early
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Gregory GilotUniversity, hospital or other
- Collaborators
- LifeNet Health, The Cleveland Clinic
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Posted 19 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is to evaluate the effectiveness of the ArthroFLEX® ECM scaffold graph as an augment in rotator cuff repair surgery to reduce the failure rate of rotator cuff repairs for large and massive rotator cuff tears.
Detailed description
This is a prospective, randomized, controlled, multi-center clinical trial to evaluate the effectiveness of an ECM scaffold graft to augment repair of a large/massive rotator cuff tear. The study will involve 70 patients. 35 patients will be randomly assigned to each arm of the study.
Despite advances in surgical technology, repairs of large (3-5 cm) and massive (>5 cm) rotator cuff tears (RCT) fail between 20%-90% of the time [1]. Due to their size and increased structural involvement, large or massive RCT present a substantial challenge to orthopaedic surgeons. [16] The repairs tend to fail at the suture-tendon junction, which is due to several factors, including tension at the repair and quality of the tendon [1-2,5]. Full thickness tears are uncommon in younger patients, especially those less than forty years old and are usually traumatic in etiology. Younger patients also typically fair better following arthroscopic rotator cuff repair with fewer failures and more successful return to pre-injury level of function [16]. One strategy to augment repair of large to massive rotator cuff tears has been the development of biological scaffold materials, which are composed of extracellular matrix (ECM). The ECM composing the scaffolds are made from a number of tissues, including, but not limited to, small intestinal submucosa (SIS), dermis, and pericardium [3]. Studies to date include both prospective and retrospective in animal and human models, and include Restore, a porcine-derived SIS by DePuy Orthopaedics, GraftJacket, a human-derived, non-cross-linked dermis graft by Wright Medical Technology, and Zimmer Collagen Repair, a cross-linked porcine derived dermal graft made by Zimmer. Restore studies have shown no benefit and some even an increase in repair failure with recommendations not to use to augment repair. GraftJacket studies have shown a reduction in graft failure; however, several of the Restore and GraftJacket studies are limited by a lack of a control cohort. The Zimmer graft studies have conflicting results with both an improvement and no improvement in failure rates of repair. The prior studies listed are all in vivo; however, the majority are not randomized trials and thus do not have a control with which to compare data. In addition, some trials include open repairs. A lack of prospective, randomized, controlled, in vivo trials exist that evaluate the ability of the ECM scaffold graft augmentation in large to massive arthroscopic rotator cuff repairs to decrease the failure rate.
The purpose of this study is to evaluate the efficacy of using the Arthroflex (A-FLEX) graft to augment large to massive arthroscopic rotator cuff repairs in vivo and decrease repair failures in a prospective, randomized, controlled trial. By undergoing serial US examinations at follow-ups, we also intend to evaluate when during the postoperative period the failure of the repair occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Treatment Group | Active comparator | Procedure: ControlPatients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. |
| Treatment Group | Active comparator | Procedure: ArthroFLEX ECM scaffold graftPatients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. |
| Alternative Treatment Group | Other | Biological: Alternative Treatment GroupPatients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a large (2.5-5 cm) to massive (>5 cm) rotator cuff tear who will be undergoing open or arthroscopic repair. The cuff tear size will be determined on either pre-operative magnetic resonance imaging (MRI), or ultrasound (US), or intra-operative measurements, or computerized tomography (CT).
- Patients who are willing and able to provide written informed consent for their involvement in the study.
- Patients who meet criteria for RCR surgery
- Patients older than 18 years of age
Key exclusion criteria (6 listed)
- Those with a known sensitivity to materials of porcine origin.
- Patients with addiction to illegal drugs, solvents or alcohol who are actively using or have previously attempted and failed a treatment program.
- Patients with bacteremia, a systemic infection, or infection of the surgical site.
- All those who are prisoners.
- Patients who are pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArthroFLEX ECM scaffold graftAlso: Surgery with ECM graftIn patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions. | Procedure or surgery | Treatment Group |
| ControlAlso: Surgery without ECM graftThis group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft. | Procedure or surgery | Control Treatment Group |
| Alternative Treatment GroupAlso: Repair cannot be accomplishedPatients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. | Biological | Alternative Treatment Group |
Primary outcome
Tendon Healing
Time frame: As assessed 1 year postoperatively.
Success as defined by tendon healing after rotator cuff repair, as indicated based on MRI
Comparison of Healing by MRI vs US
Time frame: As assessed 1 year postoperatively.
Comparison of tendon healing will be assessed using US imaging modalities versus MRI (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Progress of Tendon Healing
Time frame: As assessed at 6 weeks postoperatively.
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Progress of Tendon Healing
Time frame: As assessed at 3 months postoperatively.
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Progress of Tendon Healing
Time frame: As assessed at 6 months postoperatively.
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Progress of Tendon Healing
Time frame: As assessed at 9 months postoperatively.
Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
42 secondary outcomes
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
Time frame: Preoperative
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
Time frame: 6 weeks after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
Time frame: 3 months after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
Time frame: 6 months after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
Time frame: 9 months after surgery
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
Time frame: 1 year after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
Time frame: Preoperative
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
Time frame: 6 weeks after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
Time frame: 3 months after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
Time frame: 6 months after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
Time frame: 9 months after surgery
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)
Time frame: 1 year after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
Time frame: Preoperative
Patient Outcomes: Measurement of Shoulder Activity Level
Time frame: 6 weeks after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
Time frame: 3 months after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
Time frame: 6 months after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
Time frame: 9 months after surgery
Patient Outcomes: Measurement of Shoulder Activity Level
Time frame: 1 year after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
Time frame: Preoperative
Patient Outcomes: Subjective Shoulder Value (SSV)
Time frame: 6 weeks after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
Time frame: 3 months after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
Time frame: 6 months after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
Time frame: 9 months after surgery
Patient Outcomes: Subjective Shoulder Value (SSV)
Time frame: 1 year after surgery
Patient Outcomes: Constant Score (CS)
Time frame: Preoperative
Patient Outcomes: Constant Score (CS)
Time frame: 6 weeks after surgery
Patient Outcomes: Constant Score (CS)
Time frame: 3 months after surgery
Patient Outcomes: Constant Score (CS)
Time frame: 6 months after surgery
Patient Outcomes: Constant Score (CS)
Time frame: 9 months after surgery
Patient Outcomes: Constant Score (CS)
Time frame: 1 year after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
Time frame: Preoperative
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
Time frame: 6 weeks after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
Time frame: 3 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
Time frame: 6 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
Time frame: 9 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)
Time frame: 1 year after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
Time frame: Preoperative
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
Time frame: 6 weeks after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
Time frame: 3 months after surgery
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)
Time frame: 6 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20189415Derwin KA, Badylak SF, Steinmann SP, Iannotti JP. Extracellular matrix scaffold devices for rotator cuff repair. J Shoulder Elbow Surg. 2010 Apr;19(3):467-76. doi: 10.1016/j.jse.2009.10.020. Epub 2010 Feb 26.
- Background: PubMed 16210577Schlegel TF, Hawkins RJ, Lewis CW, Motta T, Turner AS. The effects of augmentation with Swine small intestine submucosa on tendon healing under tension: histologic and mechanical evaluations in sheep. Am J Sports Med. 2006 Feb;34(2):275-80. doi: 10.1177/0363546505279912. Epub 2005 Oct 6.
- Background: PubMed 18938117Badylak SF, Freytes DO, Gilbert TW. Extracellular matrix as a biological scaffold material: Structure and function. Acta Biomater. 2009 Jan;5(1):1-13. doi: 10.1016/j.actbio.2008.09.013. Epub 2008 Oct 2.
- Background: PubMed 15383811Sclamberg SG, Tibone JE, Itamura JM, Kasraeian S. Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced with porcine small intestinal submucosa. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):538-41. doi: 10.1016/j.jse.2004.03.005.
- Background: PubMed 16757756Iannotti JP, Codsi MJ, Kwon YW, Derwin K, Ciccone J, Brems JJ. Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears. A randomized, controlled trial. J Bone Joint Surg Am. 2006 Jun;88(6):1238-44. doi: 10.2106/JBJS.E.00524.
- Background: PubMed 17403801Walton JR, Bowman NK, Khatib Y, Linklater J, Murrell GA. Restore orthobiologic implant: not recommended for augmentation of rotator cuff repairs. J Bone Joint Surg Am. 2007 Apr;89(4):786-91. doi: 10.2106/JBJS.F.00315.
- Background: PubMed 15736287Zheng MH, Chen J, Kirilak Y, Willers C, Xu J, Wood D. Porcine small intestine submucosa (SIS) is not an acellular collagenous matrix and contains porcine DNA: possible implications in human implantation. J Biomed Mater Res B Appl Biomater. 2005 Apr;73(1):61-7. doi: 10.1002/jbm.b.30170.
- Background: PubMed 18375271Bond JL, Dopirak RM, Higgins J, Burns J, Snyder SJ. Arthroscopic replacement of massive, irreparable rotator cuff tears using a GraftJacket allograft: technique and preliminary results. Arthroscopy. 2008 Apr;24(4):403-409.e1. doi: 10.1016/j.arthro.2007.07.033.
- Background: PubMed 18201655Badhe SP, Lawrence TM, Smith FD, Lunn PG. An assessment of porcine dermal xenograft as an augmentation graft in the treatment of extensive rotator cuff tears. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):35S-39S. doi: 10.1016/j.jse.2007.08.005.
- Background: PubMed 17939470Soler JA, Gidwani S, Curtis MJ. Early complications from the use of porcine dermal collagen implants (Permacol) as bridging constructs in the repair of massive rotator cuff tears. A report of 4 cases. Acta Orthop Belg. 2007 Aug;73(4):432-6.
- Background: PubMed 16205147Brophy RH, Beauvais RL, Jones EC, Cordasco FA, Marx RG. Measurement of shoulder activity level. Clin Orthop Relat Res. 2005 Oct;439:101-8. doi: 10.1097/01.blo.0000173255.85016.1f.
- Background: PubMed 29156071Parnes N, Bartoszewski NR, Defranco MJ. Arthroscopic Repair of Full-Thickness Rotator Cuff Tears in Active Patients Younger Than 40 Years: 2- to 5-Year Clinical Outcomes. Orthopedics. 2018 Jan 1;41(1):e52-e57. doi: 10.3928/01477447-20171114-02. Epub 2017 Nov 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory J Gilot, MD principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ArthroFLEX ECM scaffold graft and Alternative Treatment Group in people with Rotator Cuff Tear, run by Gregory Gilot at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon Healing (time frame: As assessed 1 year postoperatively.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03551509, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.