Clinical trial NCT05360654: Superior Capsular Reconstruction With InternalBrace Study
Official title: Superior Capsular Reconstruction With InternalBrace for Irreparable Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superior Capsular Reconstruction
Keywords: Irreparable Rotator Cuff Tears
Lead sponsor: Wrightington, Wigan and Leigh NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Edge Hill University
name: University of Central Lancashire
First posted: 2022-05-04
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best).
timeFrame: Baseline
measure: To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best)
timeFrame: 6 months
measure: To investigate the change in clinical outcome following SCRIB using the Oxford Shoulder Score. Score scale 0 (worst) - 48 (best)
timeFrame: 12 months
Secondary outcomes:
measure: 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).
timeFrame: Baseline
measure: To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).
timeFrame: 6 months
measure: To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).
timeFrame: 12 months
measure: To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)
timeFrame: Baseline
measure: To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)
timeFrame: 6 months
measure: To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)
timeFrame: 12 months
measure: To investigate the difference in clinical outcome following SCRIB using the American Shoulder and Elbow surgeons score: Score scale 0 (worst) - 100 (best)
timeFrame: Baseline
measure: To investigate the difference in clinical outcome following SCRIB using the American Shoulder and Elbow surgeons score: Score scale 0 (worst) - 100 (best)
timeFrame: 6 months
measure: To investigate the difference in clinical outcome following SCRIB using the American Shoulder and Elbow surgeons score: Score scale 0 (worst) - 100 (best)
timeFrame: 12 months
measure: EuroQol Quality of Life Index
timeFrame: Baseline
measure: EuroQol Quality of Life Index
timeFrame: 6 months
measure: EuroQol Quality of Life Index
timeFrame: 12 months
measure: Visual Analouge Scale. Score scale 0 (best) - 100 (worst)
timeFrame: Baseline
measure: Visual Analouge Scale. Score scale 0 (best) - 100 (worst)
timeFrame: 6 months
measure: Visual Analouge Scale. Score scale 0 (best) - 100 (worst)
timeFrame: 12 months
measure: Radiological healing - historic data comparison using Magnetic Resonance Imaging
timeFrame: 12 months
measure: Graft healing measured by Magnetic Resonance Imaging
timeFrame: 12 months
Other outcomes:
Locations:
city: Wigan
country: United Kingdom
facility: Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
name: Puneet Monga
role: PRINCIPAL_INVESTIGATOR
References: