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

  puneet.monga@wwl.nhs.uk

• Sponsor organisation

  Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

• Duration of Study in the UK

  2 years, 11 months, 27 days

• Research summary

  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.

• 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