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
r.hackney@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Mr Roger Hackney
ORCID ID
Contact details
Chapel Allerton Hospital
Leeds
LS7 4SA
United Kingdom
-
r.hackney@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OR11/10063
Study information
Scientific title
Shoulder PAtch for Rotator Cuff tears: an exploratory study
Acronym
SPARC
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
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please email Dr Kingsbury (S.R.Kingsbury@leeds.ac.uk) to request a patient information sheet
Condition
Massive rotator cuff tears
Intervention
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
Procedure/Surgery
Phase
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
17/09/2013
Overall trial end date
01/11/2017
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
60
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
17/09/2013
Recruitment end date
30/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Chapel Allerton Hospital
Leeds
LS7 4SA
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals Charitable Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NIHR Leeds Musculoskeletal Biomedical Research Unit (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 (s.r.kingsbury@leeds.ac.uk)
Intention to publish date
01/09/2018
Participant level data
Available on request
Basic results (scientific)
Publication list