Superior Capsular Reconstruction With InternalBrace Study

NCT05360654 | Completed

• 1 other identifier: SCRIB
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Superior Capsular Reconstruction

Keywords

Irreparable Rotator Cuff Tears

Outcome Measures

Primary Outcomes (3)

• 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 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).

  Baseline

• To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).

  6 months

• To investigate the difference in clinical outcome following SCRIB using the Constant Shoulder Score. Score scale 0 (best) - 100 (worst).

  12 months

• To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)

  Baseline

• To investigate the difference in clinical outcome following SCRIB using the Subjective shoulder value: Score scale 0 (worst) - 100 (best)

  6 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wrightington, Wigan and Leigh NHS Foundation Trust: lead
• Edge Hill University: collaborator
• University of Central Lancashire: collaborator

Study Sites (1)

Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Wigan, WN6 9EP, United Kingdom

Location

Study Officials

• Puneet Monga

  Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: May 4, 2022
• Study Start: February 22, 2022
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)