Superior Capsular ReconstructionSCRIBNCT05360654
Superior Capsular Reconstruction With InternalBrace Study
An observational study of Superior Capsular Reconstruction, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of the study is to investigate the clinical and radiological outcomes after superior capsular reconstruction with InternalBrace (SCRIB) performed for irreparable rotator cuff tears. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Superior Capsular Reconstruction
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Feb 2022to 24 Mar 2025
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with massive rotator cuff tears that have failed surgical management and are suitable for superior capsular reconstruction.
Who may be able to join
- Adult patients between 18 and 80 years old.
- Massive Rotator cuff tears (Patte stage 3), as visualised on the MRI Scan
- Failure of non-surgical treatment.
- Patients consenting for allograft usage
- Arthroscopic assessment identifying an irreparable tear. A rotator cuff tear is deemed irreparable if it is not possible to achieve complete cover-age of the humeral head following arthroscopic release.
Who cannot join
- Pre-operative
- Patients with neurological cause of weakness
- Patients with advanced arthritis affecting the joint (Kellgren-Lawrence Grade 3 to 4)
- Fixed Humeral head superior displacement (Hamada Grade 3 to 4)
- Intra-operative
- Advanced cartilage loss
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, WN6 9EP
About this study
Official title: Superior Capsular Reconstruction With InternalBrace for Irreparable Rotator Cuff Tears
The aim of the study is to investigate the clinical and radiological outcomes after superior capsular reconstruction with InternalBrace (SCRIB) performed for irreparable rotator cuff tears.
Read the detailed description
Massive rotator cuff tears which are irreparable in adults without severe gleno-humeral joint osteoarthritis pose a challenging problem. Tendon retraction, muscle atrophy and fatty infiltration often contribute to failure of repair and poor outcomes. Re-tears following primary repairs pose similar challenges. Such rotator cuff tears can be painful and functionally limiting in active individuals. The options for treatment include joint preservation techniques like debridement and subacromial decompression, partial repair, tendon transfers, InSpace balloon insertion and patch augmentation. However, all these procedures have historically led to suboptimal outcomes when compared with complete repair. Joint sacrificing or prosthetic joint replacement options include hemi-arthroplasty and reverse shoulder arthroplasty. These are not always appropriate in young participants with minimal arthritis due to concerns regarding prosthesis failure and the potential need of multiple revision surgeries in the future.
SCR is a more recently introduced technique presenting a viable alternative in this group of participants. This was first described by Hanada et al. and subsequently popularised by Mihata et al. This technique utilises either an autograft such as fascia lata, or dermal allograft to restore the superior capsule and prevent proximal migration of the humeral head. A biomechanical study has shown that SCR restores stability in the superior direction, thereby preventing abrasion and graft failure through subacromial impingement. In a recently published multiple retrospective case series, this technique showed improved functional outcomes whilst reducing pain. A recent retrospective case series of SCR at Wrightington Hospital confirmed the safety profile of this operation. 77% of participants were noted to be pain free post-operatively and were able to return to 'normal activities'. However, there are significant methodological limitations related to such retrospective studies. These studies are either the original work of the proposer of surgery, or retrospective series. Such studies remain limited in terms of wider applicability. National Institute of Health and Care Excellence (NICE), UK, has issued guidance highlighting the limitation of quality and quantity of available evidence related to this procedure. The guidance recommends the use of SCR in context of research alone. Recent studies have raised concerns related to incidence of graft failure following SCR. It is unclear what predisposes a certain patient group to graft failure. It has been suggested that addition of an InternalBrace as an additional step during SCR surgery may improve graft healing and reduce graft re-rupture rates. This is known as superior capsular reconstruction with InternalBrace (SCRIB). The investigators propose to perform a prospective study involving clinical (standardised outcome scores) and radiological (MRI scans) outcomes following SCRIB. The Investigators propose to compare graft healing rates following SCRIB versus historical controls where SCR was performed without InternalBrace.
- Conditions
- Superior Capsular Reconstruction
- Keywords
- Irreparable Rotator Cuff Tears
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best).
The Oxford Shoulder score is a 12-item patient reported outcome measure developed to assess out-comes after shoulder surgery and provide reliable, valid, and sensitive assessments of shoulder symptoms and function. The scale consists of four pain related items and eight functional items. Higher scores correlate with a better outcome.
Measured: Baseline
To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best)
The Oxford Shoulder score is a 12-item patient reported outcome measure developed to assess out-comes after shoulder surgery and provide reliable, valid, and sensitive assessments of shoulder symptoms and function. The scale consists of four pain related items and eight functional items. Higher scores correlate with a better outcome.
Measured: 6 months
To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best)
The Oxford Shoulder score is a 12-item patient reported outcome measure developed to assess out-comes after shoulder surgery and provide reliable, valid, and sensitive assessments of shoulder symptoms and function. The scale consists of four pain related items and eight functional items. Higher scores correlate with a better outcome.
Measured: 12 months
Secondary outcomes (17)
To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. o investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).
The Constant Shoulder Score is an 8-item investigator reported outcome measure widely accepted and commonly used to assess outcomes following shoulder treatments. There are four sub-scales; patients are asked to rate their pain (15 points) and activity levels (20 points). Next, strength (25 points) and range of movement (40 points) are measured. A higher score is indicative of higher quality function. The score has been reported as reliable, responsive, and valid in assessing the impact of shoulder treatments.
Measured: Baseline
To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).
The Constant Shoulder Score is an 8-item investigator reported outcome measure widely accepted and commonly used to assess outcomes following shoulder treatments. There are four sub-scales; patients are asked to rate their pain (15 points) and activity levels (20 points). Next, strength (25 points) and range of movement (40 points) are measured. A higher score is indicative of higher quality function. The score has been reported as reliable, responsive, and valid in assessing the impact of shoulder treatments.
Measured: 6 months
To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).
The Constant Shoulder Score is an 8-item investigator reported outcome measure widely accepted and commonly used to assess outcomes following shoulder treatments. There are four sub-scales; patients are asked to rate their pain (15 points) and activity levels (20 points). Next, strength (25 points) and range of movement (40 points) are measured. A higher score is indicative of higher quality function. The score has been reported as reliable, responsive, and valid in assessing the impact of shoulder treatments.
Measured: 12 months
To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)
The Subjective shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Subjective shoulder value has been shown to be an easily administered, responsive and valid measure of shoulder function.
Measured: Baseline
To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)
The Subjective shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Subjective shoulder value has been shown to be an easily administered, responsive and valid measure of shoulder function.
Measured: 6 months
To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)
The Subjective shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Subjective shoulder value has been shown to be an easily administered, responsive and valid measure of shoulder function.
Measured: 12 months
To investigate the difference in clinical outcome following SCRIB using the American Shoulder and Elbow surgeons score: Score scale 0 (worst) - 100 (best)
The American Shoulder and Elbow surgeons score is a 17-item, 100-point scale evaluating pain and function in shoulder disorders. A higher score indicates a lower level of disability.
Measured: Baseline
To investigate the difference in clinical outcome following SCRIB using the American Shoulder and Elbow surgeons score: Score scale 0 (worst) - 100 (best)
The American Shoulder and Elbow surgeons score is a 17-item, 100-point scale evaluating pain and function in shoulder disorders. A higher score indicates a lower level of disability.
Measured: 6 months
To investigate the difference in clinical outcome following SCRIB using the American Shoulder and Elbow surgeons score: Score scale 0 (worst) - 100 (best)
The American Shoulder and Elbow surgeons score is a 17-item, 100-point scale evaluating pain and function in shoulder disorders. A higher score indicates a lower level of disability.
Measured: 12 months
EuroQol Quality of Life Index
The EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. The EQ- 5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by marking the box against the most appropriate statement in each of the 5 dimensions. The EQ VAS then records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are la-belled 'Best imaginable health state' and 'Worst imaginable health state'. This in-formation can be used as a quantitative measure of health outcome as judged by the individual respondents.
Measured: Baseline
EuroQol Quality of Life Index
The EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. The EQ- 5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by marking the box against the most appropriate statement in each of the 5 dimensions. The EQ VAS then records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are la-belled 'Best imaginable health state' and 'Worst imaginable health state'. This in-formation can be used as a quantitative measure of health outcome as judged by the individual respondents.
Measured: 6 months
EuroQol Quality of Life Index
The EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. The EQ- 5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by marking the box against the most appropriate statement in each of the 5 dimensions. The EQ VAS then records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are la-belled 'Best imaginable health state' and 'Worst imaginable health state'. This in-formation can be used as a quantitative measure of health outcome as judged by the individual respondents.
Measured: 12 months
Visual Analouge Scale. Score scale 0 (best) - 100 (worst)
To investigate the difference in clinical outcome following SCRIB using the Visual Analouge Scale.
Measured: Baseline
Visual Analouge Scale. Score scale 0 (best) - 100 (worst)
To investigate the difference in clinical outcome following SCRIB using the Visual Analouge Scale.
Measured: 6 months
Visual Analouge Scale. Score scale 0 (best) - 100 (worst)
To investigate the difference in clinical outcome following SCRIB using the Visual Analouge Scale.
Measured: 12 months
Radiological healing - historic data comparison using Magnetic Resonance Imaging
All patients will undergo clinical diagnostic preoperative Magnetic Resonance Imaging in the work up for rotator cuff surgery. This will be used at baseline to compare with the post-operative Magnetic Resonance Imaging scan at 1 year from surgery. The Magnetic Resonance Imaging will be performed using current standard protocols for shoulder Magnetic Resonance Imaging containing axial, coronal, and sagittal sequences. Magnetic Resonance Imaging will be reported by a Musculoskeletal consultant radiologist. Graft healing would be assessed, and any healing failures would be qualified as 'graft intact' or 'graft failed'.
Measured: 12 months
Graft healing measured by Magnetic Resonance Imaging
To assess graft healing measured by magnetic resonance scan imaging at 12 months post operatively.
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 posted4 May 2022
- Study start22 Feb 2022
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Capsular ReconstructionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Edge Hill University, University of Central Lancashire
- Responsible party
- Sponsor
- Investigators
- Puneet Monga, Principal investigator, Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360654
- Sponsor's protocol ID
- SCRIB
- Acronym
- SCRIB
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Capsular Reconstruction With InternalBrace for Irreparable Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT05360654
- Acronym / sponsor ID
- SCRIB / SCRIB
- Conditions
- Superior Capsular Reconstruction
- Keywords
- Irreparable Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Edge Hill University, University of Central Lancashire
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 4 May 2022 (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 aim of the study is to investigate the clinical and radiological outcomes after superior capsular reconstruction with InternalBrace (SCRIB) performed for irreparable rotator cuff tears.
Detailed description
Massive rotator cuff tears which are irreparable in adults without severe gleno-humeral joint osteoarthritis pose a challenging problem. Tendon retraction, muscle atrophy and fatty infiltration often contribute to failure of repair and poor outcomes. Re-tears following primary repairs pose similar challenges. Such rotator cuff tears can be painful and functionally limiting in active individuals. The options for treatment include joint preservation techniques like debridement and subacromial decompression, partial repair, tendon transfers, InSpace balloon insertion and patch augmentation. However, all these procedures have historically led to suboptimal outcomes when compared with complete repair. Joint sacrificing or prosthetic joint replacement options include hemi-arthroplasty and reverse shoulder arthroplasty. These are not always appropriate in young participants with minimal arthritis due to concerns regarding prosthesis failure and the potential need of multiple revision surgeries in the future.
SCR is a more recently introduced technique presenting a viable alternative in this group of participants. This was first described by Hanada et al. and subsequently popularised by Mihata et al. This technique utilises either an autograft such as fascia lata, or dermal allograft to restore the superior capsule and prevent proximal migration of the humeral head. A biomechanical study has shown that SCR restores stability in the superior direction, thereby preventing abrasion and graft failure through subacromial impingement. In a recently published multiple retrospective case series, this technique showed improved functional outcomes whilst reducing pain. A recent retrospective case series of SCR at Wrightington Hospital confirmed the safety profile of this operation. 77% of participants were noted to be pain free post-operatively and were able to return to 'normal activities'. However, there are significant methodological limitations related to such retrospective studies. These studies are either the original work of the proposer of surgery, or retrospective series. Such studies remain limited in terms of wider applicability. National Institute of Health and Care Excellence (NICE), UK, has issued guidance highlighting the limitation of quality and quantity of available evidence related to this procedure. The guidance recommends the use of SCR in context of research alone. Recent studies have raised concerns related to incidence of graft failure following SCR. It is unclear what predisposes a certain patient group to graft failure. It has been suggested that addition of an InternalBrace as an additional step during SCR surgery may improve graft healing and reduce graft re-rupture rates. This is known as superior capsular reconstruction with InternalBrace (SCRIB). The investigators propose to perform a prospective study involving clinical (standardised outcome scores) and radiological (MRI scans) outcomes following SCRIB. The Investigators propose to compare graft healing rates following SCRIB versus historical controls where SCR was performed without InternalBrace.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with massive rotator cuff tears that have failed surgical management and are suitable for superior capsular reconstruction.
Key inclusion criteria (5 listed)
- Adult patients between 18 and 80 years old.
- Massive Rotator cuff tears (Patte stage 3), as visualised on the MRI Scan
- Failure of non-surgical treatment.
- Patients consenting for allograft usage
- Arthroscopic assessment identifying an irreparable tear. A rotator cuff tear is deemed irreparable if it is not possible to achieve complete cover-age of the humeral head following arthroscopic release.
Key exclusion criteria (6 listed)
- Pre-operative
- Patients with neurological cause of weakness
- Patients with advanced arthritis affecting the joint (Kellgren-Lawrence Grade 3 to 4)
- Fixed Humeral head superior displacement (Hamada Grade 3 to 4)
- Intra-operative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best).
Time frame: Baseline
The Oxford Shoulder score is a 12-item patient reported outcome measure developed to assess out-comes after shoulder surgery and provide reliable, valid, and sensitive assessments of shoulder symptoms and function. The scale consists of four pain related items and eight functional items. Higher scores correlate with a better outcome.
To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best)
Time frame: 6 months
The Oxford Shoulder score is a 12-item patient reported outcome measure developed to assess out-comes after shoulder surgery and provide reliable, valid, and sensitive assessments of shoulder symptoms and function. The scale consists of four pain related items and eight functional items. Higher scores correlate with a better outcome.
To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best)
Time frame: 12 months
The Oxford Shoulder score is a 12-item patient reported outcome measure developed to assess out-comes after shoulder surgery and provide reliable, valid, and sensitive assessments of shoulder symptoms and function. The scale consists of four pain related items and eight functional items. Higher scores correlate with a better outcome.
17 secondary outcomes
To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. o investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).
Time frame: Baseline
To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).
Time frame: 6 months
To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).
Time frame: 12 months
To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)
Time frame: Baseline
To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)
Time frame: 6 months
To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)
Time frame: 12 months
To investigate the difference in clinical outcome following SCRIB using the American Shoulder and Elbow surgeons score: Score scale 0 (worst) - 100 (best)
Time frame: Baseline
To investigate the difference in clinical outcome following SCRIB using the American Shoulder and Elbow surgeons score: Score scale 0 (worst) - 100 (best)
Time frame: 6 months
To investigate the difference in clinical outcome following SCRIB using the American Shoulder and Elbow surgeons score: Score scale 0 (worst) - 100 (best)
Time frame: 12 months
EuroQol Quality of Life Index
Time frame: Baseline
EuroQol Quality of Life Index
Time frame: 6 months
EuroQol Quality of Life Index
Time frame: 12 months
Visual Analouge Scale. Score scale 0 (best) - 100 (worst)
Time frame: Baseline
Visual Analouge Scale. Score scale 0 (best) - 100 (worst)
Time frame: 6 months
Visual Analouge Scale. Score scale 0 (best) - 100 (worst)
Time frame: 12 months
Radiological healing - historic data comparison using Magnetic Resonance Imaging
Time frame: 12 months
Graft healing measured by Magnetic Resonance Imaging
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 2 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Superior Capsular Reconstruction
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Latissimus Dorsi Tendon Transfer vs. Superior Capsular Reconstruction in Massive Rotator Cuff Tears
Massive Rotator Cuff Tears
Not yet recruiting
Outcomes of Massive Rotator Cuff Tendon Tear Treatment.
Rotator Cuff Tears, Rotator Cuff Syndrome
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.
Puneet Monga principal investigator
Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superior Capsular Reconstruction, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
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 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
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?
To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best). (time frame: Baseline). 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 2 Apr 2025.