Rotator Cuff TearNCT01025037
Outcomes in Rotator Cuff Repair Using Graft Reinforcement
A study testing Conexa Reconstructive Tissue Matrix in people with Rotator Cuff Tear, run by Stryker Trauma and Extremities at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Conexa Reconstructive Tissue Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2009to Apr 2014
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient:
- is an adult male or female between the ages of 40-70 years old;
- has repairable primary large retracted two-tendon rotator cuff tears measuring from 3 cm to 5 cm;
- requires surgical repair of single rotator cuff (i.e. one limb);
- has movement of the non-operative arm defined as shoulder elevation of equal to or greater than 90 degrees and is able to perform postoperative exercises;
- is able to return for all scheduled and required study visits;
- is able to provide written informed consent for study participation.
Who cannot join
- The patient:
- has irreparable large rotator cuff tears that are found intra-operatively. Note: irreparable is defined by the inability to approximate the tendon to the tuberosity without tension;
- has a rotator cuff tear < 3cm (measured intra-operatively);
- has a rotator cuff tear > 5cm (measured intra-operatively);
- has a rotator cuff tear where the subscapularis tendon is disrupted/requires repair;
- has grade 3 or 4 fatty infiltration of the rotator cuff;
Show all 18Show fewer
- has had prior surgical repair to the affected shoulder;
- is American Society of Anesthesiologists (ASA) Class 4 or 5 (See Appendix I);
- is a tobacco user; unless tobacco free 6 months prior to surgery and willing to remain tobacco free for the duration of the study.
- has lower limb injuries requiring walking assist devices such as crutches and walkers;
- has a known collagen disorder, including systemic lupus erythematous (SLE), rheumatoid arthritis (RA), polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome.
- has obstacles that pose an inordinately high surgical risk, in the judgment of the certified surgeon;
- has co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, chronic steroid use, malnourishment, cancer, or co-existent infection;
- has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction;
- is enrolled or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial;
- has any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate.
- has an inability to have a closed MRI conducted.
- needs a re-operation for a re-tear of the rotator cuff.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Rush University Medical Center
Chicago, Illinois, 60612
Duke University Medical Center
Durham, North Carolina, 27710
West Virginia University
Morgantown, West Virginia, 26506
OrthoNeuro
New Albany, Ohio, 43054
Rotheman Institute
Philadelphia, Pennsylvania, 19107
Orthopaedic Clinical Association
Phoenix, Arizona, 85016
About this study
Official title: A Prospective, Multi-Center, Single-Arm Study to Assess Clinical Outcomes In Primary Open or Mini-Open Rotator Cuff Repair Using Conexa Graft Reinforcement
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
Read the detailed description
Conexa is a surgical mesh derived from porcine dermis and processed to produce an acellular dermal matrix. It is designed to perform as a surgical mesh for use as a soft tissue patch to reinforce soft tissue where weaknesses exist and for the surgical repair of damaged or ruptured soft tissue membranes. The purpose of this post-market clinical study is to collect safety and efficacy data when Conexa is used to repair torn tendons of the rotator cuff. Conexa will be used in accordance with its labeling for this clinical study.
- Conditions
- Rotator Cuff Tear
- Being tested
- Conexa Reconstructive Tissue Matrix
- Keywords
- Rotator Cuff Tear, Large, Massive, Rotator, Cuff. Tear
- 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.
Conexa Reconstructive Tissue MatrixDevice
Also called Conexa, Conexa TM
Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures
| Study group | Role | What they receive |
|---|---|---|
| Conexa Reconstructive Tissue Matrix | Other | Conexa will be placed as a soft tissue reinforcement at the rotator cuff repair site Receives: Device: Conexa Reconstructive Tissue Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Score (ASES)
The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, \& Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.
Measured: baseline, post-op months 3, 6, 12, and 24
Adjusted Constant-Murley Score
The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living - sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller \& Uhl, 2005).
Measured: baseline, post-op months 6, 12, and 24
Simple Shoulder Test (SST)
The Simple Shoulder Test (SST): a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure \& Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome.
Measured: baseline, post-op months 3, 6, 12, and 24
Secondary outcomes (2)
Rotator Cuff Re-tear Evaluation
Subjects will have MRI to assess healing of the repaired tendon at 6 and 12 months post-op. The rate of re-tear will be reported.
Two different definitions of a re-tear were used for the analysis.
- Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size.
- Sub-analysis: Full thickness tear one centimeter or greater in length.
Measured: Post-op months 6 and 12
Isometric Strength
Measured: baseline, post-op months 6, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2014
- Study completionApr 2014
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.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LifeCell
- Responsible party
- Sponsor
- Investigators
- Joseph Iannotti, MD, Study director, Cleveland, OHJohn Sperling, MD, Study director, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025037
- Sponsor's protocol ID
- Tornier-LIFC LFC2008.03.02
- Status last verified
- Jan 2015
- First submitted
- 1 Dec 2009
- Last updated
- 26 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single-Arm Study to Assess Clinical Outcomes In Primary Open or Mini-Open Rotator Cuff Repair Using Conexa Graft Reinforcement
- ClinicalTrials.gov ID
- NCT01025037
- Acronym / sponsor ID
- Tornier-LIFC LFC2008.03.02
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff Tear, Large, Massive, Rotator, Cuff. Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Collaborators
- LifeCell
- Study start
- Oct 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
Detailed description
Conexa is a surgical mesh derived from porcine dermis and processed to produce an acellular dermal matrix. It is designed to perform as a surgical mesh for use as a soft tissue patch to reinforce soft tissue where weaknesses exist and for the surgical repair of damaged or ruptured soft tissue membranes. The purpose of this post-market clinical study is to collect safety and efficacy data when Conexa is used to repair torn tendons of the rotator cuff. Conexa will be used in accordance with its labeling for this clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conexa Reconstructive Tissue Matrix | Other | Device: Conexa Reconstructive Tissue MatrixConexa will be placed as a soft tissue reinforcement at the rotator cuff repair site |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- is an adult male or female between the ages of 40-70 years old;
- has repairable primary large retracted two-tendon rotator cuff tears measuring from 3 cm to 5 cm;
- requires surgical repair of single rotator cuff (i.e. one limb);
- has movement of the non-operative arm defined as shoulder elevation of equal to or greater than 90 degrees and is able to perform postoperative exercises;
- is able to return for all scheduled and required study visits;
Key exclusion criteria (18 listed)
- has irreparable large rotator cuff tears that are found intra-operatively. Note: irreparable is defined by the inability to approximate the tendon to the tuberosity without tension;
- has a rotator cuff tear < 3cm (measured intra-operatively);
- has a rotator cuff tear > 5cm (measured intra-operatively);
- has a rotator cuff tear where the subscapularis tendon is disrupted/requires repair;
- has grade 3 or 4 fatty infiltration of the rotator cuff;
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 |
|---|---|---|
| Conexa Reconstructive Tissue MatrixAlso: Conexa, Conexa TMConexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures | Device | Conexa Reconstructive Tissue Matrix |
Primary outcome
American Shoulder and Elbow Score (ASES)
Time frame: baseline, post-op months 3, 6, 12, and 24
The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, \& Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.
Adjusted Constant-Murley Score
Time frame: baseline, post-op months 6, 12, and 24
The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living - sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller \& Uhl, 2005).
Simple Shoulder Test (SST)
Time frame: baseline, post-op months 3, 6, 12, and 24
The Simple Shoulder Test (SST): a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure \& Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome.
2 secondary outcomes
Rotator Cuff Re-tear Evaluation
Time frame: Post-op months 6 and 12
Isometric Strength
Time frame: baseline, post-op months 6, 12, and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rotator Cuff Tear
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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.
Joseph Iannotti, MD study director
Cleveland, OH
John Sperling, MD study director
Rochester, MN
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conexa Reconstructive Tissue Matrix in people with Rotator Cuff Tear, run by Stryker Trauma and Extremities at 6 sites 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2015). 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?
American Shoulder and Elbow Score (ASES) (time frame: baseline, post-op months 3, 6, 12, and 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2015.