Clinical trial NCT02049684: SPARC: Shoulder PAtch for Rotator Cuff Tears
Official title: SPARC: Shoulder PAtch for Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Massive Rotator Cuff Tears
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Massive rotator cuff tear patients

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in supraspinatus, infraspinatous and subscapularis water:fat ratio
timeFrame: Baseline and 6 months post surgery
Secondary outcomes:
measure: Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score)
timeFrame: Baseline and 6 months post surgery
measure: Change in muscle volume (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
timeFrame: Baseline and 6 months post-surgery
measure: Change in Goutallier score of muscle atrophy and fatty infiltration (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
timeFrame: Baseline and 6 months post-surgery
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
Study officials:
References: