Superior Capsular Reconstruction With InternalBrace Study (SCRIB)

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.

Study Overview

• Status: Completed
• Conditions: Superior Capsular Reconstruction

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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United Kingdom
  • Wigan, United Kingdom, WN6 9EP
    • Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults with massive rotator cuff tears that have failed surgical management and are suitable for superior capsular reconstruction.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline
Visual Analouge Scale. Score scale 0 (best) - 100 (worst)	To investigate the difference in clinical outcome following SCRIB using the Visual Analouge Scale.	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.	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'.	12 months
Graft healing measured by Magnetic Resonance Imaging	To assess graft healing measured by magnetic resonance scan imaging at 12 months post operatively.	12 months

Collaborators and Investigators

• Sponsor: Wrightington, Wigan and Leigh NHS Foundation Trust
• Collaborators: University of Central Lancashire; Edge Hill University
• Investigators: Principal Investigator: Puneet Monga, Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): March 24, 2025
• Study Completion (Actual): March 24, 2025

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Irreparable Rotator Cuff Tears
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: SCRIB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No