Shoulder patch for rotator cuff tears
| ISRCTN | ISRCTN79844053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79844053 |
| ClinicalTrials.gov number | NCT02049684 |
| Secondary identifying numbers | OR11/10063 |
- Submission date
- 15/10/2014
- Registration date
- 30/12/2014
- Last edited
- 09/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Chapel Allerton Hospital
Leeds
LS7 4SA
United Kingdom
 ORCID ID |
0000-0002-9917-1269 |
|---|---|
| Phone | +44(0)113 392 4878 |
| S.R.Kingsbury@leeds.ac.uk |
Study information
| Study design | Exploratory study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please email Dr Kingsbury (S.R.Kingsbury@leeds.ac.uk) to request a patient information sheet |
| Scientific title | Shoulder PAtch for Rotator Cuff tears: an exploratory study |
| Study acronym | SPARC |
| Study objectives | 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(s) | NRES Committee Yorkshire & The Humber - Leeds West, 04/03/2013, ref: 13/YH/0030 |
| Health condition(s) or problem(s) studied | 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 | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 17/09/2013 |
| Completion date | 01/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 68 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/09/2013 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
LS7 4SA
United Kingdom
Sponsor information
Hospital/treatment centre
R&D department
34 Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom
"ROR" |
https://ror.org/00v4dac24 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 31/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer reviewed journal within one year of trial completion |
| IPD sharing plan | 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/04/2020 | 09/04/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
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 Clinicaltrials.gov 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.
