Rotator Cuff TearsSCRNCT04965103
Superior Capsule vs Bridging Study
A study testing SCR and Bridging in people with Rotator Cuff Tears, run by University of Calgary.
Trial summary
Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- SCR and Bridging
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively)
- Either primary tear or re-tear after previous repair
- Radiographic evidence of Hamada stage 1-3, with or without Samilson \& Prieto mild osteoarthritis (<3mm inferior osteophyte)
Who cannot join
- Primary glenohumeral osteoarthritis: radiographic evidence of Samilson \& Prieto classification moderate or greater
- Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above
- Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis)
- Medical issues precluding surgery
- Unwilling or unable to complete study outcomes
- Worker's Compensation Claim or litigation
About this study
Official title: Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition
Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears.
Read the detailed description
RCT n = 50
Groups:
- bridging
- SCR
Outcomes:
- WORC
- ASES
- QuickDASH
- MRI at 12 months post-op
- Conditions
- Rotator Cuff Tears
- Being tested
- SCR, Bridging
- Keywords
- irreparable
- 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.
SCRProcedure or surgery
Superior Capsule reconstruction
BridgingProcedure or surgery
Tendon repair with graft interposition
| Study group | Role | What they receive |
|---|---|---|
| Bridging | Active comparator | Tendon repair with graft interposition Receives: Procedure: Bridging |
| SCR | Experimental | Superior Capsule reconstruction Receives: Procedure: SCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeon Outcome - patient portion
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
Measured: 24 months
American Shoulder and Elbow Surgeon Outcome - patient portion
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
Measured: 12 months
American Shoulder and Elbow Surgeon Outcome - patient portion
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
Measured: 6 months
American Shoulder and Elbow Surgeon Outcome - patient portion
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
Measured: 3 months
Secondary outcomes (9)
Western Ontario Rotator Cuff Index
Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
Measured: 24 months
Western Ontario Rotator Cuff Index
Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
Measured: 12 months
Western Ontario Rotator Cuff Index
Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
Measured: 6 months
Western Ontario Rotator Cuff Index
Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
Measured: 3 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH
Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
Measured: 24 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH
Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
Measured: 12 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH
Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
Measured: 6 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH
Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
Measured: 3 months
Tendon healing, assessed via MRI
Tendon healing (classifications: intact or retorn)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Jan 2016
- Primary completion7 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Worker's Compensation Board of Alberta (funding), Canadian Orthopaedic Foundation (funding), Arthroscopy Association of North America
- Responsible party
- Sponsor
- Investigators
- Ian Lo, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965103
- Sponsor's protocol ID
- REB15-1787
- Acronym
- SCR
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition
- ClinicalTrials.gov ID
- NCT04965103
- Acronym / sponsor ID
- SCR / REB15-1787
- Conditions
- Rotator Cuff Tears
- Keywords
- irreparable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Worker's Compensation Board of Alberta (funding), Canadian Orthopaedic Foundation (funding), Arthroscopy Association of North America
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 7 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Jul 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.
Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears.
Detailed description
RCT n = 50
Groups:
- bridging
- SCR
Outcomes:
- WORC
- ASES
- QuickDASH
- MRI at 12 months post-op
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridging | Active comparator | Procedure: BridgingTendon repair with graft interposition |
| SCR | Experimental | Procedure: SCRSuperior Capsule reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively)
- Either primary tear or re-tear after previous repair
- Radiographic evidence of Hamada stage 1-3, with or without Samilson \& Prieto mild osteoarthritis (<3mm inferior osteophyte)
Key exclusion criteria (6 listed)
- Primary glenohumeral osteoarthritis: radiographic evidence of Samilson \& Prieto classification moderate or greater
- Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above
- Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis)
- Medical issues precluding surgery
- Unwilling or unable to complete study outcomes
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 |
|---|---|---|
| SCRSuperior Capsule reconstruction | Procedure or surgery | SCR |
| BridgingTendon repair with graft interposition | Procedure or surgery | Bridging |
Primary outcome
American Shoulder and Elbow Surgeon Outcome - patient portion
Time frame: 24 months
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
American Shoulder and Elbow Surgeon Outcome - patient portion
Time frame: 12 months
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
American Shoulder and Elbow Surgeon Outcome - patient portion
Time frame: 6 months
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
American Shoulder and Elbow Surgeon Outcome - patient portion
Time frame: 3 months
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
9 secondary outcomes
Western Ontario Rotator Cuff Index
Time frame: 24 months
Western Ontario Rotator Cuff Index
Time frame: 12 months
Western Ontario Rotator Cuff Index
Time frame: 6 months
Western Ontario Rotator Cuff Index
Time frame: 3 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH
Time frame: 24 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH
Time frame: 12 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH
Time frame: 6 months
Disabilities of the Arm, Shoulder and Hand - QuickDASH
Time frame: 3 months
Tendon healing, assessed via MRI
Time frame: 12 months
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 16 Jul 2021.
- Individual participant dataSharing planned: No. No plan to share individual participant data.
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
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.
Ian Lo, MD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing SCR and Bridging in people with Rotator Cuff Tears, run by University of Calgary.
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 3 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: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
American Shoulder and Elbow Surgeon Outcome - patient portion (time frame: 24 months). The study lists 4 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 16 Jul 2021.