Partial rotator cuff tear repair trial
| ISRCTN | ISRCTN60983694 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60983694 |
| IRAS number | 283908 |
| Secondary identifying numbers | HTA - NIHR128043, PID15009 |
- Submission date
- 22/06/2020
- Registration date
- 02/07/2020
- Last edited
- 27/11/2024
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Rotator cuff tears are tendon tears in the shoulder that cause pain, weakness and loss of movement. These tears can be full tears through the whole tendon or only partway through - a partial tear. People affected have problems with day-to-day activities, work, recreation and sleep. Partial tears are first treated in the NHS with physiotherapy and often a steroid injection. Patients who do not get better with these treatments may then choose to have surgery. This study aims to assess if surgical repair of partial tears, in patients with persistent pain despite physiotherapy, is effective. The study is important because, even though rotator cuff problems are the most common cause of shoulder pain and disability, it remains unknown how best to treat them and whether surgery has any extra value. In particular, it is not known whether repairing partial tears prevents bigger full tears and worsening problems. Surgery for full tears is one of the most common shoulder operations in the UK. Prevention of full tears was identified as important by patients and doctors in the 2015 James Lind Alliance Priority Setting Partnership (PSP) for Surgery for Common Shoulder Conditions (4 of the top 10 priorities were about rotator cuff problems). The main aim of this study is therefore to find out if repairing these partial tears is effective, provides lasting benefit and prevents bigger tears.
Who can participate?
Patients aged over 18 with a partial thickness tear
What does the study involve?
The study will compare two similar procedures: arthroscopic debridement with arthroscopic repair (ADAR) which involves arthroscopic (keyhole) surgery to debride (shave away inflamed tissue, rough tear edges, and bone spurs) and repair the tear. ADAR will be compared to arthroscopic debridement only (ADO) which involves arthroscopic surgery to debride only (shave away inflamed tissue, rough tear edges, and bone spurs) without any repair.
For each participant the type of surgery received will be chosen at random by a computer programme. Participants will complete a questionnaire at five timepoints. One will be completed before surgery takes place. Four more questionnaires will be sent at 6, 12, 24 months and 5 years after surgery. Each questionnaire takes around 10 minutes to fill out and will be completed at home; online or on paper according to participant preference. At the 5-year timepoint, as well as asking participants to complete a questionnaire, the researchers will request routine information on further treatment or problems relating to the shoulder from NHS Digital (Hospital Episodes Statistics). In addition to the questionnaires, 2 years after surgery, participants will be asked to undergo an MRI scan at their local hospital.
What are the possible benefits and risks of participating?
Outside of the usual risks associated with surgery and anaesthetic, there are no anticipated risks or disadvantages to participating in the study. Both procedures are already performed routinely in the NHS, and there is no expected difference in the risk between them, or between treatment outside of the study. The main benefit of taking part in the study will be the information the participant provides which will help to improve treatment in the future. The results of the study are likely to benefit future NHS patients with shoulder complaints.
Where is the study run from?
Surgical Intervention Trials Unit (SITU) and Oxford Clinical Trials and Research Unit (OCTRU) at the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford (UK)
When is the study starting and how long is it expected to run for?
January 2020 to September 2027
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
SITU-NDORMS Team, situ@ndorms.ox.ac.uk
Contact information
Public, Scientific
The Botnar Research Centre
Windmill Road, Headington
Oxford
OX3 7LD
United Kingdom
| Phone | +44 (0)1865227684 |
|---|---|
| procure@ndorms.ox.ac.uk |
Study information
| Study design | Multi-centre parallel patient blinded two-arm randomized controlled trial with integrated QuinteT Recruitment Intervention (QRI) to support recruitment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The clinical and cost-effectiveness of surgical repair of partial rotator cuff tears in patients with subacromial shoulder pain: a comparison of surgical repair versus surgery with no repair |
| Study acronym | PRoCuRe |
| Study objectives | In patients with a suspected partial-thickness rotator cuff tear and subacromial shoulder pain listed for arthroscopic surgery, is ADAR (Arthroscopic Debridement and Arthroscopic Repair) more beneficial than ADO (Arthroscopic Debridement Only) as measured by pain reduction and functional restoration at 24 months post-operation? |
| Ethics approval(s) | Approved 05/03/2021, London Central REC (London - Central Research Ethics Committee, 3rd Floor, Barlow House, 4, Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8225; londoncentral.rec@hra.nhs.uk), ref: 21/LO/0081 |
| Health condition(s) or problem(s) studied | Subacromial pain and suspected partial-thickness rotator cuff tear |
| Intervention | PRoCuRe is a randomised controlled trial with 1:1 allocation. Patient eligibility for randomisation will be confirmed during surgery. Eligible patients will be randomised in theatre to receive one of the two possible interventions: Arthroscopic Debridement and Arthroscopic Repair (ADAR) or Arthroscopic Debridement Only (ADO). Arthroscopic Debridement with Arthroscopic Repair (ADAR) involves arthroscopic (keyhole) surgery to debride (shave away inflamed tissue, rough tear edges, and bone spurs) and repair the tear. ADAR will be compared to Arthroscopic Debridement Only (ADO) which involves arthroscopic surgery to debride only (shave away inflamed tissue, rough tear edges, and bone spurs) without any repair. For each participant the type of surgery received will be chosen at random by a computer programme. Participants will undertake a questionnaire at 5 timepoints. One will be completed before surgery takes place (baseline). Four more questionnaires will be sent at 6, 12, 24 months and 5 years after surgery. Each questionnaire takes around 10 minutes to fill out and will be completed at home; online or on paper according to participant preference. At the 5-year timepoint, as well as asking participants to complete a questionnaire, the researchers will request routine information on further treatment or problems relating to the shoulder from NHS Digital (Hospital Episodes Statistics). In addition to the questionnaires, 2 years after surgery, participants will be asked to undergo an MRI scan at their local hospital. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain and function measured using the Oxford Shoulder Score (OSS) at 24 months post-randomisation |
| Secondary outcome measures | 1. Pain and function measured using the Oxford Shoulder Score (OSS) at baseline, 6, 12 months, and 5 years post-randomisation 2. Quality of life measured using EQ-5D-5L at baseline, 6, 12, 24 months and 5 years post-randomisation 3. Patient use of health resources assessed using a health resource use questionnaire at 6, 12, and 24 months post-randomisation 4. Patient satisfaction and perception assessed using satisfaction and perception questionnaire at 6, 12, and 24 months post-randomisation 5. Progression to full-thickness cuff tears assessed through MRI imaging at 24 months post-randomisation 6. Readmission for further surgery and associated costs assessed by routinely collected observational hospital data (HES) at 5 years post-randomisation |
| Overall study start date | 01/01/2020 |
| Completion date | 30/09/2027 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | It is anticipated that, to achieve the target 270 randomised participants, around 386 patients will be recruited |
| Key inclusion criteria | 1. Over 18 years of age 2. Willing and able to provide informed consent 3. MRI or USS suggesting a Partial Thickness Tear (PTT) diagnosis is Supraspinatus 4. An understanding of the English language sufficient to receive written and verbal information about the trial, its consent process and complete study questionnairesMRI or USS suggesting a PTT diagnosis in Supraspinatus Inclusion Criteria for randomisation (confirmed in surgery) 5. PTT more than 50% tendon thickness confirmed in Supraspinatus during arthroscopy |
| Key exclusion criteria | 1. Patient has not had 6 months of physiotherapy 2. Patient has not had at least one steroid injection 3. Steroid injection within 6 weeks of planned surgery date 4. No Partial Thickness Tear (PTT) 5. PTT less than 50% tendon thickness 6. Any full-thickness tears on imaging or at surgery 7. Inflammatory arthritis (e.g. rheumatoid) 8. Glenohumeral osteoarthritis 9. Current active malignancy of any kind 10. Tears associated with acute fractures 11. Tears associated with shoulder dislocations 12. Upper limb neurological deficit on either side 13. Unable to undergo MRI 14. Unable to complete the written follow-up questionnaires |
| Date of first enrolment | 01/07/2021 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
Sponsor information
University/education
Joint Research Office
1st Floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
England
United Kingdom
| Phone | +44 (0)1865 289885 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Private sector organisation / Research institutes and centers
- Alternative name(s)
- NIHR Biomedical Research Centre, Oxford, OxBRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/11/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Additional documents such as the study protocol and statistical analysis plan will be available. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the study closing early with minimal data collected. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Preprint results | 12/06/2023 | 01/11/2023 | No | No |
Editorial Notes
27/11/2024: IRAS number added, contact details updated.
01/11/2023: Preprint publication added.
19/10/2022: The study was stopped due to low recruitment. Contact details and IPD sharing statement updated.
08/07/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/06/2021 to 01/07/2021.
2. The recruitment end date has been changed from 31/05/2023 to 30/06/2023.
26/05/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/05/2021 to 01/06/2021.
2. The recruitment end date has been changed from 30/04/2023 to 31/05/2023.
16/03/2021: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 01/03/2021 to 01/05/2021.
3. The recruitment end date was changed from 28/02/2023 to 30/04/2023.
06/01/2021: The following changes were made to the trial record:
1. Ethics approval details added.
2. The recruitment start date was changed from 01/01/2021 to 01/03/2021.
3. The recruitment end date was changed from 31/12/2022 to 28/02/2023.
15/09/2020: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2020 to 01/01/2021.
2. The recruitment end date has been changed from 01/09/2022 to 31/12/2022.
23/06/2020: Trial's existence confirmed by the NIHR.
