Superior Capsular Reconstruction With InternalBrace Study

NCT ID: NCT05360654

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2025-03-24

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.

Conditions

Superior Capsular Reconstruction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Edge Hill University

OTHER

Sponsor Role: collaborator

University of Central Lancashire

OTHER

Sponsor Role: collaborator

Wrightington, Wigan and Leigh NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Puneet Monga

Role: PRINCIPAL_INVESTIGATOR

Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Locations

Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Wigan, , United Kingdom

Countries

United Kingdom

Other Identifiers

SCRIB

Identifier Type: -

Identifier Source: org_study_id