An observational study in Massive Rotator Cuff Tears, sponsored by The Leeds Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Observational
Rotator cuff tears (injury to the muscle or tendons which stabilise the shoulder) are one of the most common conditions affecting the shoulder. Small and medium sized rotator cuff tears can be managed with arthroscopic or keyhole surgery. Very large or massive tears are difficult to operate on and often have poor rates of healing. As a result surgeons have investigated the use of products to improve the outcome of surgery on massive tears.
The product that the investigators are currently using to try to improve the outcome of surgery for massive rotator cuff tears is called a patch. The patch provides a scaffold to support the muscles of the rotator cuff. Studies of rotator cuff surgery using similar patches have found that recovery is improved and there is a lower rate of postsurgical problems. The aim of this study is to look at whether using the patch improves pain and the clinical function of the shoulder after surgery. In addition, the investigators would like to understand how the patch works. To do this the investigators will scan (take images of) the shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder before and after surgery.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 60 is below the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Massive rotator cuff tear patients
Exclusion Criteria:
Subjects with the following contraindications to MRI scanning will not have an MR scan but may be asked to have alternative imaging, for example ultrasound:
Procedure: Patch
Change in supraspinatus, infraspinatous and subscapularis water:fat ratio
Change in supraspinatus, infraspinatous and subscapularis water:fat ratio, assessed by MRI, 6 months postsurgery/ physiotherapy compared to baseline (presurgery/physiotherapy)
Time frame: Baseline and 6 months post surgery
Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score)
Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score)
Time frame: Baseline and 6 months post surgery
Change in muscle volume (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Change in muscle volume (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Time frame: Baseline and 6 months post-surgery
Change in Goutallier score of muscle atrophy and fatty infiltration (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Change in Goutallier score of muscle atrophy and fatty infiltration (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Time frame: Baseline and 6 months post-surgery
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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The Leeds Teaching Hospitals NHS Trust