Rotator Cuff TearSCRNCT03617562
Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears
A study testing Superior Capsular Reconstruction and Partial Repair in people with Rotator Cuff Tear, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial summary
Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Superior Capsular Reconstruction and Partial Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Jul 2018to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic shoulder pain and/ or weakness (regardless of baseline range of motion/ psuedoparalysis)
- Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus.
- Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications
- Irreparable tear determined intra-operatively using standard arthroscopic techniques
- Informed consent obtained
Who cannot join
- Absence of subscapularis muscle insertion, or irreparable subscapularis tear
- Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+)
- Acute tears (within 6 months)
- Neurologic injury causing paralysis of affected shoulder / arm
- Any previous surgery to the affected shoulder
- Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher)
- Anticipated problems with ability to maintain follow-up in the judgement of the investigators (ie. patients with no fixed address, etc.)
- Are there any non-orthopedic comorbidities that put the patient at significant risk?
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Sunnybrook Holland Orthopaedic & Arthritic Centre
Toronto, Ontario, M4Y 1H1
Patrick Henry, MD, 416-967-8701, patrick.henry@sunnybrook.ca
Ryan Paul, MD, 7808609272, rpaul2011@gmail.com
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Tim Dwyer, MD, tim.dwyer@wchospital.ca
research@utosm.com
About this study
Official title: Arthroscopic Partial Repair vs. Superior Capsular Reconstruction for Massive Irreparable Rotator Cuff Tears: A Pilot Randomized and Controlled Trial
Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established.
The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial.
Read the detailed description
The current study seeks to improve the management of patients suffering from massive irreparable rotator cuff tears. Despite several available surgical options, no level 1 evidence or randomized clinical trials have been performed in this patient population to date. Arthroscopic partial rotator cuff repair (PRCR) is arguably the gold-standard surgical option with the longest record of use. The new technique of superior capsular reconstruction (SCR) has also emerged with early biomechanical and case series showing promising results. SCR has quickly made its way into clinical practice in North America. Despite this, the effectiveness, cost, and safety profile has not been established for this procedure. As such, patients with massive irreparable rotator cuff tears are in need of high level evidence to support surgical decision making, particular with regards to the proliferation of SCR surgery.
This pilot study is a randomized, controlled, double-blinded trial comparing superior capsular reconstruction using dermal allograft with arthroscopic partial repair in patients with massive irreparable rotator cuff tears. In this study, "double-blind" includes study patients and outcome assessors. Randomization will occur intra-operatively once a tear is determined to be irreparable.
This trial will be conducted at 7 sites and involve 7 surgeons. Surgeons must meet eligibility requirements to participate (shoulder or sports fellowship-trained, minimum of 3 SCR procedures, and 25 arthroscopic rotator cuff repair procedures in the past year). A member of the local research team will pre-screen consults of eligible patients. Full eligibility will be determined during the primary appointment with an orthopaedic surgeon. Baseline data will be recorded following informed consent. Postoperative outcomes will be measured during regularly scheduled clinic visits (6 weeks, 3 months, 6 months, 1-year and 2-year post-surgery).
Prior to surgery, patients will have informed consent for both procedures, with randomization to be performed intraoperatively. Based on initial arthroscopic assessment of the shoulder, patients that have a confirmed irreparable tear will be randomized into one of two groups: arthroscopic partial repair or superior capsular reconstruction. Surgical techniques will be standardized. Allocation will be concealed using a centralized 24-hour computerized randomization system that will allow Internet-based allocation. A random number generator will be used to create a 1:1 allocation scheme for randomization of the patient into one of the two treatment groups. The post-operative therapy regimen will be the same for each group.
- Conditions
- Rotator Cuff Tear
- Being tested
- Superior Capsular Reconstruction, Partial Repair
- Keywords
- Massive Rotator Cuff Tear, Shoulder Injuries
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior Capsular ReconstructionProcedure or surgery
Residual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.
Partial RepairProcedure or surgery
Rotator cuff is repaired with residual defect remaining.
| Study group | Role | What they receive |
|---|---|---|
| Superior Capsular Reconstruction | Experimental | Patients will be treated with the new technique of superior capsular reconstruction with dermal allograft. Receives: Procedure: Superior Capsular Reconstruction |
| Partial Repair | Active comparator | Patients will have a partial repair with residual defect as an established standard procedure. Receives: Procedure: Partial Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Functional Outcome Score
Sub scales: Pain (10 cm VAS); function/disability (10 items, each rated on 4-point Likert scale for level of difficulty)
Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)
Measured: 1 year post operative
Secondary outcomes (12)
Complication rate
Incidence of minor and major complications related to each procedure.
Measured: 1 year post operative
Recruitment rate
Assessment of number of eligible patients identified and number enrolled and randomized.
Measured: 1 year post operative
Constant-Murley Score
Functional outcome score
Sub scales: Pain item (4 Likert levels), Activities of Daily Living (Likert scales), Mobility (2 points for every 30 degrees of elevation), Strength (1 point per 0.5 kg)
Score Range: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). Total score: 0-100. The higher the score, the higher the quality of the function.
Measured: 1 year post operative
Western Ontario Rotator Cuff Index
Functional outcome score
Consists of 21 visual analog scale (VAS) items organised in 5 subscales: physical symptoms, sports/recreation, work, lifestyle, and emotions.
Each item in WORC has a possible score from 0-100 (100mm VAS). Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life.
Measured: 1 year post operative
Pain: Numeric Rating Scale
Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.
Measured: 1 year post operative
Range of Motion
Measured by handheld goniometer
Measured: 1 year post operative
EQ-5D
Health Related Quality of Life
The EQ-5D questionnaire is made up for two components; health state description and evaluation.
In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.
Visual analogue scale: 20 cm vertical scale with end points of 0 and 100. 0 corresponds to " the worst health you can imagine", and 100 corresponds to "the best health you can imagine".
Measured: 1 year post operative
Xray: Acromio-Humeral Interval
Measured distance from inferior acromion to superior humeral head at the closest distance. Distance in millimetres.
Measured: 1 year post operative
Xray: Degenerative Change
Measured by Samilson-Prieto Grade:
Mild Arthritis (Grade 1): inferior humeral and/or glenoid exostosis < 3mm in height
Moderate Arthritis (Grade 2): inferior humeral and/or glenoid exostosis measuring 3mm to 7mm slight gleno-humeral irregularity
Severe Arthritis (Grade 3): inferior humeral and/or glenoid exostosis measuring > 7mm gleno-humeral joint narrowing and sclerosis
Measured: 1 year post operative
MRI - graft healing
Assess graft integrity: Healed or Torn
Measured: 1 year post operative
MRI - tear size
Assess size of recurrent tear (in maximum anterior to posterior and medial to lateral dimensions). Measured in cm.
Measured: 1 year post operative
MRI - fatty degeneration
Measured by Goutallier classification of each rotator cuff muscle:
grade 0: normal muscle grade 1: some fatty streaks grade 2: less than 50% fatty muscle atrophy grade 3: 50% fatty muscle atrophy grade 4: greater than 50% fatty muscle atrophy
Measured: 1 year post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start18 Jul 2018
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Women's College Hospital, St. Joseph's Healthcare Hamilton, The Ottawa Hospital
- Responsible party
- Sponsor
- Investigators
- Patrick Henry, MD, FRCSC, Principal investigator, Sunnybrook Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617562
- Sponsor's protocol ID
- SCR2018
- Acronym
- SCR
- Status last verified
- Jan 2026
- First submitted
- 7 May 2018
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Partial Repair vs. Superior Capsular Reconstruction for Massive Irreparable Rotator Cuff Tears: A Pilot Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT03617562
- Acronym / sponsor ID
- SCR / SCR2018
- Conditions
- Rotator Cuff Tear
- Keywords
- Massive Rotator Cuff Tear, Shoulder Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Women's College Hospital, St. Joseph's Healthcare Hamilton, The Ottawa Hospital
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 6 Aug 2018 (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.
Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established.
The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial.
Detailed description
The current study seeks to improve the management of patients suffering from massive irreparable rotator cuff tears. Despite several available surgical options, no level 1 evidence or randomized clinical trials have been performed in this patient population to date. Arthroscopic partial rotator cuff repair (PRCR) is arguably the gold-standard surgical option with the longest record of use. The new technique of superior capsular reconstruction (SCR) has also emerged with early biomechanical and case series showing promising results. SCR has quickly made its way into clinical practice in North America. Despite this, the effectiveness, cost, and safety profile has not been established for this procedure. As such, patients with massive irreparable rotator cuff tears are in need of high level evidence to support surgical decision making, particular with regards to the proliferation of SCR surgery.
This pilot study is a randomized, controlled, double-blinded trial comparing superior capsular reconstruction using dermal allograft with arthroscopic partial repair in patients with massive irreparable rotator cuff tears. In this study, "double-blind" includes study patients and outcome assessors. Randomization will occur intra-operatively once a tear is determined to be irreparable.
This trial will be conducted at 7 sites and involve 7 surgeons. Surgeons must meet eligibility requirements to participate (shoulder or sports fellowship-trained, minimum of 3 SCR procedures, and 25 arthroscopic rotator cuff repair procedures in the past year). A member of the local research team will pre-screen consults of eligible patients. Full eligibility will be determined during the primary appointment with an orthopaedic surgeon. Baseline data will be recorded following informed consent. Postoperative outcomes will be measured during regularly scheduled clinic visits (6 weeks, 3 months, 6 months, 1-year and 2-year post-surgery).
Prior to surgery, patients will have informed consent for both procedures, with randomization to be performed intraoperatively. Based on initial arthroscopic assessment of the shoulder, patients that have a confirmed irreparable tear will be randomized into one of two groups: arthroscopic partial repair or superior capsular reconstruction. Surgical techniques will be standardized. Allocation will be concealed using a centralized 24-hour computerized randomization system that will allow Internet-based allocation. A random number generator will be used to create a 1:1 allocation scheme for randomization of the patient into one of the two treatment groups. The post-operative therapy regimen will be the same for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superior Capsular Reconstruction | Experimental | Procedure: Superior Capsular ReconstructionPatients will be treated with the new technique of superior capsular reconstruction with dermal allograft. |
| Partial Repair | Active comparator | Procedure: Partial RepairPatients will have a partial repair with residual defect as an established standard procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic shoulder pain and/ or weakness (regardless of baseline range of motion/ psuedoparalysis)
- Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus.
- Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications
- Irreparable tear determined intra-operatively using standard arthroscopic techniques
- Informed consent obtained
Key exclusion criteria (8 listed)
- Absence of subscapularis muscle insertion, or irreparable subscapularis tear
- Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+)
- Acute tears (within 6 months)
- Neurologic injury causing paralysis of affected shoulder / arm
- Any previous surgery to the affected shoulder
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 Capsular ReconstructionResidual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head. | Procedure or surgery | Superior Capsular Reconstruction |
| Partial RepairRotator cuff is repaired with residual defect remaining. | Procedure or surgery | Partial Repair |
Primary outcome
The American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time frame: 1 year post operative
Functional Outcome Score Sub scales: Pain (10 cm VAS); function/disability (10 items, each rated on 4-point Likert scale for level of difficulty) Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)
12 secondary outcomes
Complication rate
Time frame: 1 year post operative
Recruitment rate
Time frame: 1 year post operative
Constant-Murley Score
Time frame: 1 year post operative
Western Ontario Rotator Cuff Index
Time frame: 1 year post operative
Pain: Numeric Rating Scale
Time frame: 1 year post operative
Range of Motion
Time frame: 1 year post operative
EQ-5D
Time frame: 1 year post operative
Xray: Acromio-Humeral Interval
Time frame: 1 year post operative
Xray: Degenerative Change
Time frame: 1 year post operative
MRI - graft healing
Time frame: 1 year post operative
MRI - tear size
Time frame: 1 year post operative
MRI - fatty degeneration
Time frame: 1 year post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- 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.
Patrick Henry, MD, FRCSC principal investigator
Sunnybrook Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superior Capsular Reconstruction and Partial Repair in people with Rotator Cuff Tear, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 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 2 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Henry, MD, FRCSC (416-967-8701, patrick.henry@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) (time frame: 1 year post operative). 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 30 Jul 2026.