SPARC: Shoulder PAtch for Rotator Cuff Tears

NCT02049684 — Completed, 60 participants, The Leeds Teaching Hospitals NHS Trust

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Registry	NCT02049684
Status	Completed
Study type	Observational
Enrollment	60 (Actual)
Sponsor	The Leeds Teaching Hospitals NHS Trust (Other)
Conditions	Massive Rotator Cuff Tears
Interventions	Patch (Procedure)
Dates	start 2013-01-01, primary completion 2018-03-31, completion 2018-03-31, first posted 2014-01-30, last updated 2019-08-19
Locations	1 site in United Kingdom

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Surgery		Procedure: Patch
Physiotherapy

Patch (Procedure)

+Outcome measures

Primary outcomes

Change in supraspinatus, infraspinatous and subscapularis water:fat ratio [Baseline and 6 months post surgery]: Change in supraspinatus, infraspinatous and subscapularis water:fat ratio, assessed by MRI, 6 months postsurgery/ physiotherapy compared to baseline (presurgery/physiotherapy)

Secondary outcomes

Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score) [Baseline and 6 months post surgery]: Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score)
Change in muscle volume (MRI assessment) for the supraspinatus, infraspinatous and subscapularis [Baseline and 6 months post-surgery]: Change in muscle volume (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 [Baseline and 6 months post-surgery]: Change in Goutallier score of muscle atrophy and fatty infiltration (MRI assessment) for the supraspinatus, infraspinatous and subscapularis

+Eligibility

Sex: All, ages: 18 Years to 95 Years

Inclusion Criteria:

* Ultrasound confirming massive rotator full thickness tear, unacceptable pain and disability following conservative treatment, or previous surgery that has failed, deltoid muscle that is functional, and compliance with post operative rehabilitation.

Exclusion Criteria:

* History of infection
* Neurological condition that affects the shoulder girdle
* Presence of rotator cuff arthropathy with stiffness
* Subjects with inability to give informed consent
* Pregnancy or lactation
* Malignancy
* Age less than 18 years
* Subjects currently participating in other research studies
* 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:

  * Pacemakers
  * Surgical clips within the head
  * Certain inner ear implants
  * Neuroelectrical stimulators
  * Metal fragments within the eye or head
  * Pregnant or breastfeeding women

+Locations (1)

Facility	City	Country	Status
Leeds Teaching Hospital NHS Trust	Leeds	United Kingdom