Scaffold Evaluation for Rotator Cuff Repair (SECuRe)
Research type
Research Study
Full title
A comparison of tissue characteristics following surgical rotator cuff repair and augmentation using three types of scaffold.
IRAS ID
191928
Contact name
Andrew Carr
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
The rotator cuff is a group of four muscles that help to stabilize the shoulder joint. Muscles are joined to bones by tendons and in the shoulder joint the most common tendon to tear is the supraspinatus. If this tendon becomes fully detached from the top of the arm bone (head of humerus) it is described as a full thickness rotator cuff tear.
Rotator cuff tears are the leading cause of shoulder pain and disability with 14% of the population in the UK reporting shoulder problems with rotator cuff problems being the most common cause of pain. Between 5% and 39% of the general population have rotator cuff tears, and prevalence is expected to increase as the population continues to age. Rotator cuff tears can have a significant impact on quality of life and every day activities including employment.
Small rotator cuff tears (tear size<3cm) can be successfully managed using conservative treatments such as steroid injections and physiotherapy. However, larger tears (tear size≥3cm) often fail to heal naturally and frequently require surgical intervention. Unfortunately, surgical repair failure remains a significant problem, with re-tear rates reported between 11% and 94%. Patients who re-tear have reduced function of their shoulder and fewer treatment options available for further management.
In order to improve the surgical outcomes of rotator cuff repairs, especially in patients with larger tears, a range of devices known as tissue scaffolds have been developed. These mesh like structures are intended to improve the stability of the repair and enhance the natural healing process.
There are three main types of scaffolds in current clinical use:
• Biological scaffolds- made from either human or mammal tissue, including porcine;
• Synthetic that are made from man-made molecules (polymers), and
• Biosynthetic - a mixture of both.Several scaffolds have been shown to work in preclinical and clinical studies. However, the precise manner by which tendon tissue responds to an implanted scaffold remains unclear. Furthermore, no previous study has directly compared the efficacy of different types of scaffold in the clinical setting.
Therefore, the purpose of this study is to observe and compare the healing response of a surgically repaired tendon with 3 different types of scaffold in current clinical use (biological, synthetic and biosynthetic) and where more traditional sutures or stiches have been used to repair the torn tendon.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0697
Date of REC Opinion
30 Dec 2015
REC opinion
Further Information Favourable Opinion