Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
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. This study is testing a new product, called a patch, which is hoped will improve the outcome of surgery for massive rotator cuff tears. 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 post-surgical problems. The aim of this study is to look at the effect of the patch on the muscles in the shoulder and to look at whether using the patch improves pain and the clinical function of the shoulder after surgery.

Who can participate?
Participants who are at least 18 years old and with massive rotator cuff tears

What does the study involve?
Participants decide, together with their surgeon, whether to have patch-assisted surgery or standard treatment (either standard surgery or non-surgical management, which involves physiotherapy). They have a scan of their shoulder to look at the muscle damage in the shoulder before and after their treatment. Participants are also asked to fill in some questionnaires about their shoulder function and pain, before and after their treatment.

What are the possible benefits and risks of participating?
There is no direct benefit to people taking part in the study. However, it is hoped this study will provide information to help improve future treatment of massive rotator cuff tears. There are no direct risks to taking part in study. No medications, including analgesics or anti-inflammatories, are withheld and treatment (surgery or physiotherapy) is not delayed in any way. Participants have an MRI scan which can be claustrophobic, but the scan can be stopped at any time if the participant is not happy. MRI scans are very safe and give no radiation.

Where is the study run from?
Leeds Teaching Hospital NHS Trust (UK)

When is the study starting and how long is it expected to run for?
September 2013 to June 2015

Who is funding the study?
1. Leeds Teaching Hospitals Charitable Foundation (UK)
2. NIHR Leeds Musculoskeletal Biomedical Research Unit (UK)

Who is the main contact?
Mr Roger Hackney

Trial website

Contact information



Primary contact

Dr Sarah Kingsbury


Contact details

Chapel Allerton Hospital
United Kingdom
+44(0)113 392 4878

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

Shoulder PAtch for Rotator Cuff tears: an exploratory study



Study hypothesis

Use of a synthetic graft to augment rotator cuff repairs will provide better improvement of clinical function of the shoulder compared to conservative treatment.

Ethics approval

NRES Committee Yorkshire & The Humber - Leeds West, 04/03/2013, ref: 13/YH/0030

Study design

Exploratory study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please email Dr Kingsbury ( to request a patient information sheet


Massive rotator cuff tears


Patients will either undergo augmented patch-assisted rotator cuff repair or conservative treatment, which may include standard surgery or non-surgical management. Treatment decision will be made by the surgeon together with the patient.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Clinical outcomes (baseline, 6 weeks, 6 months):
1. Clinical examination
2. Shoulder function and pain, measured using the Oxford Shoulder Score, Shoulder Pain and Disability Index [SPADI], Constant Score
3. Quality of life, measured using EQ5D

Imaging outcomes:
1. MRI assessment of the supraspinatus, infraspinatous and subscapularis at baseline (pre-surgery) and 6 months post-surgery: Muscle volume, Goutallier score of muscle atrophy and fatty infiltration

Secondary outcome measures

This is an exploratory study, therefore there are no defined primary and secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. All patients who are considered for patch repair
2. Ultrasound or surgery confirming massive rotator full thickness tear
3. Unacceptable pain and disability following conservative treatment or previous surgery that has failed

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. History of infection
2. Neurological condition that affects the shoulder girdle
3. Presence of rotator cuff arthropathy
4. Subjects with inability to give informed consent
5. Pregnancy or lactation
6. Malignancy
7. Age less than 18 years
8. Subjects currently participating in other research studies
9. Subjects with the following contra-indications to MRI scanning will not have an MR scan but may be asked to have alternative imaging, for example ultrasound:
9.1. Pacemakers
9.2. Surgical clips within the head
9.3. Certain inner ear implants
9.4. Neuro-electrical stimulators
9.5. Metal fragments within the eye or head
9.6. Pregnant or breastfeeding women

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Chapel Allerton Hospital
United Kingdom

Sponsor information


Leeds Teaching Hospitals NHS Trust

Sponsor details

R&D department
34 Hyde Terrace
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals Charitable Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

NIHR Leeds Musculoskeletal Biomedical Research Unit (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned publication in peer reviewed journal within one year of trial completion

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Sarah Kingsbury (

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in (added 09/04/2020)

Publication citations

Additional files

Editorial Notes

09/04/2020: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added. 17/04/2019: The following changes have been made: 1. The scientific contact has been changed from Mr Roger Hackney to Dr Sarah Kingsbury. 2. The intention to publish date has been changed from 01/09/2018 to 31/10/2019. 15/04/2019: The number has been added. 19/10/2018: The overall trial end date was updated from 01/09/2017 to 01/11/2017. 05/06/2017: The following changes were made to the trial record: 1. The overall trial end date was changed from 30/10/2014 to 01/09/2017. 2. Publication and dissemination plan and IPD sharing statement added.