Rotator Cuff TearsNCT04742452
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
A study testing Superior Capusular Reconstruction and Partial Rotator Cuff Repair in people with Rotator Cuff Tears, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
Trial summary
The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES)… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Superior Capusular Reconstruction and Partial Rotator Cuff Repair
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Nov 2020to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: ≥18 years
- Irreparable rotator cuff tear suspected on pre-operative MRI
Who cannot join
- Pregnant, illiterate, or non-English speaking individuals
- Rotator cuff pathology amenable to a complete repair intraoperatively
- Moderate to severe rotator cuff arthropathy (Hamada grade ≥3)
- Presence of glenohumeral arthritis on radiographs
- Irreparable subscapularis muscle intraoperatively
- Active infection within the ipsilateral glenohumeral joint
Show all 9Show fewer
- Neurologic pathology limiting shoulder function
- Current smoker
- Workers' compensation claim
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Lake Health
Willoughby, Ohio, 44094
About this study
The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and Patient Reported Outcomes Measurement Information System (PROMIS) 29 score at 6 weeks, 3, 6, 12, and 24 months post-operatively. The two surgical modalities of interest are partial rotator cuff repair alone and partial rotator cuff repair with superior capsule reconstruction (SCR). The secondary objective of this study is determine the failure rate of partial repair alone vs. partial repair with SCR via magnetic resonance imaging (MRI) at 12 months post-operatively. The information gained from this investigation will be useful to discern if SCR provides any benefit to patients with irreparable rotator cuff tears. The investigators hypothesize that there is no statistically significant difference in pain and functional outcomes between partial rotator cuff repair alone versus partial rotator cuff repair with SCR. In addition, the investigators hypothesize that the failure rate will be significantly higher in patients undergoing partial rotator cuff repair with SCR.
Read the detailed description
Rotator cuff injury is a commonly encountered problem within the United States. In most cases, surgical repair can reduce pain and restore baseline functional status. However, in the case of an irreparable rotator cuff tear, management becomes more challenging as these injuries tend to be larger in size, are inelastic secondary to tendon retraction, and exhibit fatty infiltration and rotator cuff atrophy1. A multitude of surgical approaches for an irreparable rotator cuff tear have been described in the literature, including partial repair alone, partial repair with superior capsular reconstruction (SCR), arthroscopic debridement, graft interposition, balloon spacer arthroplasty, tendon transfers, and reverse total shoulder arthroplasty (rTSA)2. In younger patients, the traditional approach to managing these injuries involved partial rotator cuff repair with subacromial decompression and debridement with the hopes of providing the patient with some restoration of function and pain relief3,4. Clinical studies have demonstrated that partial repair can lead to an improvement in pain and function in the early post-operative period; long-term outcomes following this procedure were less reliable3. In addition, a high rate of failure has been associated with partial rotator cuff repair alone. Partial repair with SCR is a relatively new surgical procedure that has become an increasingly popular treatment modality in recent years because of early promising biomechanical and functional outcomes5,6. However, there have been no prospective randomized assessments of SCR. Therefore, the long-term outcomes of SCR compared to the standard of care, namely partial rotator cuff repair, are unknown.
This will be a multi-center, prospective randomized controlled trial. Prior to enrollment, patients will be screened for inclusion criteria. Participants who meet the eligibility criteria and are suspected to have an irreparable rotator cuff tear will be randomized into one of the two treatment arms prior to surgery. Group 1 will receive partial rotator cuff repair alone while group 2 will receive partial rotator cuff repair with SCR. All patients with suspected irreparable rotator cuff tears will be consented in clinic. There is the potential situation where the surgeon believed that the rotator cuff tear was irreparable based on clinical and radiographic evidence but was able to completely repair the tear intraoperatively. Based on the modified intention-to-treat (mITT) principle, these select patients will be dropped from the study and will no longer be followed for research purposes. Randomization will occur with a stratified randomization excel spreadsheet. Each group will be followed post-operatively for 24 months. The primary objective of this study is to compare pain and functional outcomes between the two treatment arms. The secondary objective is to assess the failure rate between the two treatment arms.
Study Procedures
- All patients with a strongly suspected irreparable rotator cuff tear will be identified in the clinics of the treating physicians and be screened for inclusion and exclusion criteria. The consent form will be reviewed in depth with the patients by an IRB-approved member of the study team, and all questions will be answered prior to enrollment in the study. Patients will be asked if they need additional time to review the consent, and no coercion will occur throughout the consent process. Although patients will be consented at this clinic visit, they will be informed that there is a possibility that they will ultimately be excluded from the study because an irreparable rotator cuff tear can only be confirmed intraoperatively.
- At the initial pre-operative clinic visit, patient demographics will be collected and the pain and functional status of patients will be assessed using VAS, SST, ASES, and PROMIS-29 scores. It should take approximately 15 minutes to complete these surveys in clinic.
- Patients requiring medical clearance to ensure their health is optimized for surgery will do so. After receiving medical clearance (if needed), the patients will undergo surgery.
- Patients will be randomized prior to surgery into one of two possible treatment arms as described above. Stratified randomization will be performed with Microsoft Excel. If a patient, who was suspected to have an irreparable rotator cuff tear based on clinical and radiographic findings, is amenable to a complete rotator cuff tear, they will be dropped from the study and no longer followed for research purposes. This is based on the mITT principle.
- On the day of surgery, the patient will receive either a partial rotator cuff repair alone or a partial rotator cuff repair with SCR.
- Intraoperative data will be collected. For both groups, the investigators will assess if the following were performed during the procedure: subacromial decompression, biceps tenotomy vs. tenodesis, marginal convergence, single vs. double-row repair, and repair of the subscapularis muscle. For the SCR group, the size (mm2) and width (mm) of the acellular dermal allograft will be recorded. Finally, any complications that occur intraoperatively will be recorded for both groups.
- After discharge from the surgery center, both groups of patients will be given identical pain medication regimens, post-operative restrictions, and clinical follow-up schedule. They will be instructed to follow-up in clinic at 6 weeks, 3, 6, 12, and 24 months post-operatively.
- At each post-operative appointment, the patients will again be administered the VAS, SST, ASES, and PROMIS-29 questionnaires. Complications will be assessed at each visit. In addition, at the 12-month follow-up appointment, each patient in both groups will be given a prescription for an MRI of the operative shoulder to assess for failure of the repair.
- Key variables for analysis will be found within the electronic medical record, and in questionnaires administered at clinic appointments. They include: age at time of surgery, sex, height, weight, hand dominance, laterality of surgery, mechanism of injury, and surgical complications (e.g., infection, failure of repair).
- Conditions
- Rotator Cuff Tears
- Being tested
- Superior Capusular Reconstruction, Partial Rotator Cuff Repair
- Keywords
- Superior capsular reconstruction, Partial rotator cuff repair, Magnetic resonance imaging
- 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.
Superior Capusular ReconstructionProcedure or surgery
Superior capsular reconstruction is one treatment option for massive and irreparable rotator cuff tears. The superior shoulder capsule, a thin membranous structure located on the inferior surface of the supraspinatus and infraspinatus muscles, is often torn in this type of rotator cuff tear. In superior capsular reconstruction, this structure is reconstructed with acellular dermal allograft.
Partial Rotator Cuff RepairProcedure or surgery
Partial rotator cuff repair can be performed, in conjunction with other procedures such as subacromial decompression and biceps tenodesis, when a rotator cuff tear is not amenable to a complete repair.
| Study group | Role | What they receive |
|---|---|---|
| Superior Capsular Reconstruction | Active comparator | Not described Receives: Procedure: Superior Capusular Reconstruction |
| Partial Rotator Cuff Repair | Placebo comparator | Not described Receives: Procedure: Partial Rotator Cuff Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Measured: 6 weeks
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Measured: 3 months
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Measured: 6 months
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Measured: 12 months
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Measured: 24 months
American Shoulder and Elbow Society (ASES) score
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Measured: 6 weeks
American Shoulder and Elbow Society (ASES) score
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Measured: 3 months
American Shoulder and Elbow Society (ASES) score
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Measured: 6 months
American Shoulder and Elbow Society (ASES) score
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Measured: 12 months
American Shoulder and Elbow Society (ASES) score
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Measured: 24 months
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Measured: 6 weeks
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Measured: 3 months
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Measured: 6 months
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Measured: 12 months
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Measured: 24 months
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
Measured: 6 weeks
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
Measured: 3 months
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
Measured: 6 months
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
Measured: 12 months
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
Measured: 24 months
Secondary outcomes (1)
Graft/repair integrity via magnetic resonance imaging
Assessing the integrity of the repair, either SCR or the partial repair, to see if it is still intact at 12 months post-operatively.
Measured: 12-months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start24 Nov 2020
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lake Health, Midwest Orthopaedics at Rush
- Responsible party
- Principal investigator, Robert J. Gillespie, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742452
- Sponsor's protocol ID
- STUDY20201107
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2020
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bedi A, Dines J, Warren RF, Dines DM. Massive tears of the rotator cuff. J Bone Joint Surg Am. 2010 Aug 4;92(9):1894-908. doi: 10.2106/JBJS.I.01531.
PubMed 20686065Carver TJ, Kraeutler MJ, Smith JR, Bravman JT, McCarty EC. Nonarthroplasty Surgical Treatment Options for Massive, Irreparable Rotator Cuff Tears. Orthop J Sports Med. 2018 Nov 7;6(11):2325967118805385. doi: 10.1177/2325967118805385. eCollection 2018 Nov.
PubMed 30480007Cvetanovich GL, Waterman BR, Verma NN, Romeo AA. Management of the Irreparable Rotator Cuff Tear. J Am Acad Orthop Surg. 2019 Dec 15;27(24):909-917. doi: 10.5435/JAAOS-D-18-00199.
PubMed 31206436Walch G, Edwards TB, Boulahia A, Nove-Josserand L, Neyton L, Szabo I. Arthroscopic tenotomy of the long head of the biceps in the treatment of rotator cuff tears: clinical and radiographic results of 307 cases. J Shoulder Elbow Surg. 2005 May-Jun;14(3):238-46. doi: 10.1016/j.jse.2004.07.008.
PubMed 15889020Denard PJ, Brady PC, Adams CR, Tokish JM, Burkhart SS. Preliminary Results of Arthroscopic Superior Capsule Reconstruction with Dermal Allograft. Arthroscopy. 2018 Jan;34(1):93-99. doi: 10.1016/j.arthro.2017.08.265. Epub 2017 Nov 13.
PubMed 29146165Mihata T, Lee TQ, Watanabe C, Fukunishi K, Ohue M, Tsujimura T, Kinoshita M. Clinical results of arthroscopic superior capsule reconstruction for irreparable rotator cuff tears. Arthroscopy. 2013 Mar;29(3):459-70. doi: 10.1016/j.arthro.2012.10.022. Epub 2013 Jan 28.
PubMed 23369443
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT04742452
- Acronym / sponsor ID
- STUDY20201107
- Conditions
- Rotator Cuff Tears
- Keywords
- Superior capsular reconstruction, Partial rotator cuff repair, Magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Lake Health, Midwest Orthopaedics at Rush
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and Patient Reported Outcomes Measurement Information System (PROMIS) 29 score at 6 weeks, 3, 6, 12, and 24 months post-operatively. The two surgical modalities of interest are partial rotator cuff repair alone and partial rotator cuff repair with superior capsule reconstruction (SCR). The secondary objective of this study is determine the failure rate of partial repair alone vs. partial repair with SCR via magnetic resonance imaging (MRI) at 12 months post-operatively. The information gained from this investigation will be useful to discern if SCR provides any benefit to patients with irreparable rotator cuff tears. The investigators hypothesize that there is no statistically significant difference in pain and functional outcomes between partial rotator cuff repair alone versus partial rotator cuff repair with SCR. In addition, the investigators hypothesize that the failure rate will be significantly higher in patients undergoing partial rotator cuff repair with SCR.
Detailed description
Rotator cuff injury is a commonly encountered problem within the United States. In most cases, surgical repair can reduce pain and restore baseline functional status. However, in the case of an irreparable rotator cuff tear, management becomes more challenging as these injuries tend to be larger in size, are inelastic secondary to tendon retraction, and exhibit fatty infiltration and rotator cuff atrophy1. A multitude of surgical approaches for an irreparable rotator cuff tear have been described in the literature, including partial repair alone, partial repair with superior capsular reconstruction (SCR), arthroscopic debridement, graft interposition, balloon spacer arthroplasty, tendon transfers, and reverse total shoulder arthroplasty (rTSA)2. In younger patients, the traditional approach to managing these injuries involved partial rotator cuff repair with subacromial decompression and debridement with the hopes of providing the patient with some restoration of function and pain relief3,4. Clinical studies have demonstrated that partial repair can lead to an improvement in pain and function in the early post-operative period; long-term outcomes following this procedure were less reliable3. In addition, a high rate of failure has been associated with partial rotator cuff repair alone. Partial repair with SCR is a relatively new surgical procedure that has become an increasingly popular treatment modality in recent years because of early promising biomechanical and functional outcomes5,6. However, there have been no prospective randomized assessments of SCR. Therefore, the long-term outcomes of SCR compared to the standard of care, namely partial rotator cuff repair, are unknown.
This will be a multi-center, prospective randomized controlled trial. Prior to enrollment, patients will be screened for inclusion criteria. Participants who meet the eligibility criteria and are suspected to have an irreparable rotator cuff tear will be randomized into one of the two treatment arms prior to surgery. Group 1 will receive partial rotator cuff repair alone while group 2 will receive partial rotator cuff repair with SCR. All patients with suspected irreparable rotator cuff tears will be consented in clinic. There is the potential situation where the surgeon believed that the rotator cuff tear was irreparable based on clinical and radiographic evidence but was able to completely repair the tear intraoperatively. Based on the modified intention-to-treat (mITT) principle, these select patients will be dropped from the study and will no longer be followed for research purposes. Randomization will occur with a stratified randomization excel spreadsheet. Each group will be followed post-operatively for 24 months. The primary objective of this study is to compare pain and functional outcomes between the two treatment arms. The secondary objective is to assess the failure rate between the two treatment arms.
Study Procedures
- All patients with a strongly suspected irreparable rotator cuff tear will be identified in the clinics of the treating physicians and be screened for inclusion and exclusion criteria. The consent form will be reviewed in depth with the patients by an IRB-approved member of the study team, and all questions will be answered prior to enrollment in the study. Patients will be asked if they need additional time to review the consent, and no coercion will occur throughout the consent process. Although patients will be consented at this clinic visit, they will be informed that there is a possibility that they will ultimately be excluded from the study because an irreparable rotator cuff tear can only be confirmed intraoperatively.
- At the initial pre-operative clinic visit, patient demographics will be collected and the pain and functional status of patients will be assessed using VAS, SST, ASES, and PROMIS-29 scores. It should take approximately 15 minutes to complete these surveys in clinic.
- Patients requiring medical clearance to ensure their health is optimized for surgery will do so. After receiving medical clearance (if needed), the patients will undergo surgery.
- Patients will be randomized prior to surgery into one of two possible treatment arms as described above. Stratified randomization will be performed with Microsoft Excel. If a patient, who was suspected to have an irreparable rotator cuff tear based on clinical and radiographic findings, is amenable to a complete rotator cuff tear, they will be dropped from the study and no longer followed for research purposes. This is based on the mITT principle.
- On the day of surgery, the patient will receive either a partial rotator cuff repair alone or a partial rotator cuff repair with SCR.
- Intraoperative data will be collected. For both groups, the investigators will assess if the following were performed during the procedure: subacromial decompression, biceps tenotomy vs. tenodesis, marginal convergence, single vs. double-row repair, and repair of the subscapularis muscle. For the SCR group, the size (mm2) and width (mm) of the acellular dermal allograft will be recorded. Finally, any complications that occur intraoperatively will be recorded for both groups.
- After discharge from the surgery center, both groups of patients will be given identical pain medication regimens, post-operative restrictions, and clinical follow-up schedule. They will be instructed to follow-up in clinic at 6 weeks, 3, 6, 12, and 24 months post-operatively.
- At each post-operative appointment, the patients will again be administered the VAS, SST, ASES, and PROMIS-29 questionnaires. Complications will be assessed at each visit. In addition, at the 12-month follow-up appointment, each patient in both groups will be given a prescription for an MRI of the operative shoulder to assess for failure of the repair.
- Key variables for analysis will be found within the electronic medical record, and in questionnaires administered at clinic appointments. They include: age at time of surgery, sex, height, weight, hand dominance, laterality of surgery, mechanism of injury, and surgical complications (e.g., infection, failure of repair).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superior Capsular Reconstruction | Active comparator | Procedure: Superior Capusular Reconstruction |
| Partial Rotator Cuff Repair | Placebo comparator | Procedure: Partial Rotator Cuff Repair |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age range: ≥18 years
- Irreparable rotator cuff tear suspected on pre-operative MRI
Key exclusion criteria (9 listed)
- Pregnant, illiterate, or non-English speaking individuals
- Rotator cuff pathology amenable to a complete repair intraoperatively
- Moderate to severe rotator cuff arthropathy (Hamada grade ≥3)
- Presence of glenohumeral arthritis on radiographs
- Irreparable subscapularis muscle intraoperatively
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 |
|---|---|---|
| Superior Capusular ReconstructionSuperior capsular reconstruction is one treatment option for massive and irreparable rotator cuff tears. The superior shoulder capsule, a thin membranous structure located on the inferior surface of the supraspinatus and infraspinatus muscles, is often torn in this type of rotator cuff tear. In superior capsular reconstruction, this structure is reconstructed with acellular dermal allograft. | Procedure or surgery | Superior Capsular Reconstruction |
| Partial Rotator Cuff RepairPartial rotator cuff repair can be performed, in conjunction with other procedures such as subacromial decompression and biceps tenodesis, when a rotator cuff tear is not amenable to a complete repair. | Procedure or surgery | Partial Rotator Cuff Repair |
Primary outcome
Pain Visual Analog Scale (VAS)
Time frame: 6 weeks
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Time frame: 3 months
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Time frame: 6 months
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Time frame: 12 months
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Time frame: 24 months
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
American Shoulder and Elbow Society (ASES) score
Time frame: 6 weeks
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
American Shoulder and Elbow Society (ASES) score
Time frame: 3 months
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
American Shoulder and Elbow Society (ASES) score
Time frame: 6 months
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
American Shoulder and Elbow Society (ASES) score
Time frame: 12 months
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
American Shoulder and Elbow Society (ASES) score
Time frame: 24 months
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Simple Shoulder Test (SST)
Time frame: 6 weeks
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Simple Shoulder Test (SST)
Time frame: 3 months
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Simple Shoulder Test (SST)
Time frame: 6 months
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Simple Shoulder Test (SST)
Time frame: 12 months
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Simple Shoulder Test (SST)
Time frame: 24 months
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Time frame: 6 weeks
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Time frame: 3 months
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Time frame: 6 months
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Time frame: 12 months
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Time frame: 24 months
29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.
1 secondary outcome
Graft/repair integrity via magnetic resonance imaging
Time frame: 12-months post-operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 20686065Bedi A, Dines J, Warren RF, Dines DM. Massive tears of the rotator cuff. J Bone Joint Surg Am. 2010 Aug 4;92(9):1894-908. doi: 10.2106/JBJS.I.01531.
- Background: PubMed 30480007Carver TJ, Kraeutler MJ, Smith JR, Bravman JT, McCarty EC. Nonarthroplasty Surgical Treatment Options for Massive, Irreparable Rotator Cuff Tears. Orthop J Sports Med. 2018 Nov 7;6(11):2325967118805385. doi: 10.1177/2325967118805385. eCollection 2018 Nov.
- Background: PubMed 31206436Cvetanovich GL, Waterman BR, Verma NN, Romeo AA. Management of the Irreparable Rotator Cuff Tear. J Am Acad Orthop Surg. 2019 Dec 15;27(24):909-917. doi: 10.5435/JAAOS-D-18-00199.
- Background: PubMed 15889020Walch G, Edwards TB, Boulahia A, Nove-Josserand L, Neyton L, Szabo I. Arthroscopic tenotomy of the long head of the biceps in the treatment of rotator cuff tears: clinical and radiographic results of 307 cases. J Shoulder Elbow Surg. 2005 May-Jun;14(3):238-46. doi: 10.1016/j.jse.2004.07.008.
- Background: PubMed 29146165Denard PJ, Brady PC, Adams CR, Tokish JM, Burkhart SS. Preliminary Results of Arthroscopic Superior Capsule Reconstruction with Dermal Allograft. Arthroscopy. 2018 Jan;34(1):93-99. doi: 10.1016/j.arthro.2017.08.265. Epub 2017 Nov 13.
- Background: PubMed 23369443Mihata T, Lee TQ, Watanabe C, Fukunishi K, Ohue M, Tsujimura T, Kinoshita M. Clinical results of arthroscopic superior capsule reconstruction for irreparable rotator cuff tears. Arthroscopy. 2013 Mar;29(3):459-70. doi: 10.1016/j.arthro.2012.10.022. Epub 2013 Jan 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superior Capusular Reconstruction and Partial Rotator Cuff Repair in people with Rotator Cuff Tears, run by University Hospitals Cleveland Medical Center at 3 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 2 inclusion and 9 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Visual Analog Scale (VAS) (time frame: 6 weeks). The study lists 20 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 NCT04742452, which also lists 6 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 6 Jul 2026.