SPARC: Shoulder PAtch for Rotator Cuff Tears

Massive Rotator Cuff Tears Clinical Trial

Official title:

SPARC: Shoulder PAtch for Rotator Cuff Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049684
• Other study ID #: OR11/10063
• Secondary ID: 13/YH/0030
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: March 31, 2018

Study information

• Verified date: August 2019
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Massive Rotator Cuff Tears
• Rotator Cuff Injuries

Intervention

Procedure:
• Patch

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospital NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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