SPARC: Shoulder PAtch for Rotator Cuff Tears

NCT02049684 | Completed

• 2 other identifiers: OR11/1006313/YH/0030
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Massive Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  Baseline and 6 months post-surgery

• Change in Goutallier score of muscle atrophy and fatty infiltration (MRI assessment) for the supraspinatus, infraspinatous and subscapularis

  Baseline and 6 months post-surgery

Study Arms (2)

Surgery

Procedure: Patch

Physiotherapy

Interventions

Patch PROCEDURE

Surgery

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Massive rotator cuff tear patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospital NHS Trust

Leeds, LS7 4SA, United Kingdom

Location

MeSH Terms

Interventions

Transdermal Patch

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 30, 2014
• Study Start: January 1, 2013
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

GB (1)