Superior Capsule Recontruction with InternalBrace (SCRIB) V1
Research type
Research Study
Full title
Superior Capsular Reconstruction with InternalBrace for Irreparable Rotator Cuff Tears
IRAS ID
300788
Contact name
Puneet Monga
Contact email
Sponsor organisation
Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 27 days
Research summary
Summary of Research
The rotator cuff muscles surround the shoulder joint, helping to keep it stable. Unfortunately, rotator cuff tendon tears are common, causing pain, affecting function and quality of life. Regrettably, in some cases surgical repair of the tear is impossible and current alternative surgical treatments have unreliable outcomes. Hence, irreparable rotator cuff tears (IRCT) are challenging to treat.
A newer surgical technique can improve shoulder joint stability in some people with IRCT. The operation, called ‘superior capsular reconstruction’ (SCR) uses a graft of donated tissue fixed to the bones at the top of the shoulder joint and any remaining rotator cuff. Studies have already shown that this procedure is safe and successful, with over 80% of patients satisfied after surgery. When people aren’t satisfied after surgery, it may be because the graft hasn’t healed. An additional technique has been developed called an ‘InternalBrace’, designed to improve healing and outcomes. The InternalBrace in conjunction with the SCR is known as SCRIB.
Currently there is not enough high-quality research supporting the choice of this operation for people with IRCT. As importantly, we do not know enough about how the addition of InternalBrace affects healing or clinical outcomes. Because of this the National Institute of Health and Care Excellence (NICE) have recommended SCR only be offered within a clinical trial. Hence, in this current study we plan to follow a group of at least 25 patients having SCRIB, for at least a year. Our primary aim is to assess the safety and effectiveness of SCRIB using standard patient reported outcome measures and magnetic resonance imaging. Furthermore, we plan to compare the results with a previous group of participants who have the SCR without the InternalBrace. We will present the outcome of the study and hope to improve future treatment of IRCT.Summary of Results
This study looked at outcomes after a shoulder operation called Superior Capsular Reconstruction with InternalBrace (SCRIB). It examined both how patients felt and managed day to day activities after surgery, and if the repair healed well on MRI scans. Results were also compared with a previous group of patients who had the same surgery without the added InternalBrace.Patients who had SCRIB showed clear improvements in shoulder function. Scores that measure pain, movement, and daily activities all improved. Movement of the arm forwards and out to the side also increased. However, outward (external) rotation of the shoulder did not improve at one year after surgery. Overall, these results are in line with previous studies of this type of surgery.
When we looked at healing on MRI scans after one year, there was no meaningful difference between patients who had SCRIB and those who had the standard surgery. In the SCRIB group, 29% of repairs were fully healed. This rate is lower than some earlier reports, likely because this study only included more severe tears that could not be repaired by other methods.
We also looked at where the repair had healed within the shoulder. The aim was to see whether healing in certain areas led to better patient outcomes. In particular, we explored whether healing on the upper arm bone side might improve results by acting as a cushion in the joint. However, we did not find any clear link between healing location and patient outcomes.
The procedure was found to be safe. No complications directly related to the surgery were reported, and the adverse events recorded were not directly related to the implant.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/PR/1140
Date of REC Opinion
19 Oct 2021
REC opinion
Further Information Favourable Opinion