SPARC: Shoulder PAtch for Rotator Cuff Tears

NCT ID: NCT02049684

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2018-03-31

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgery

Patch

Intervention Type: PROCEDURE

Physiotherapy

No interventions assigned to this group

Interventions

Patch

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospital NHS Trust

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

13/YH/0030

Identifier Type: OTHER

Identifier Source: secondary_id

OR11/10063

Identifier Type: -

Identifier Source: org_study_id