Superior Capsular Reconstruction With InternalBrace Study

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Superior Capsular Reconstruction With InternalBrace for Irreparable Rotator Cuff Tears

Conditions
-----------------
Superior Capsular Reconstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irreparable Rotator Cuff Tears