SPARC: Shoulder PAtch for Rotator Cuff Tears

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.

Study Overview

• Status: Completed
• Conditions: Massive Rotator Cuff Tears
• Intervention / Treatment: Procedure: Patch

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS7 4SA
    • Leeds Teaching Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Massive rotator cuff tear patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery	Procedure: Patch
Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and 6 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	Baseline and 6 months post-surgery

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: OR11/10063; 13/YH/0030 (Other Identifier: Research Ethics Committee)