Plain English Summary
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?
PRoCuRe Trial Manager
Mrs Naomi Merritt
The Botnar Research Centre
Mrs Naomi Merritt
The Botnar Research Centre
HTA - NIHR128043, PID15009
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
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?
Multi-centre parallel patient blinded two-arm randomised controlled trial with integrated QuinteT Recruitment Intervention (QRI) to support recruitment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Subacromial pain and suspected partial-thickness rotator cuff tear
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.
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 trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
It is anticipated that, to achieve the target 270 randomised participants, around 386 patients will be recruited
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Nuffield Orthopedic Centre, Oxford University Hospitals NHS Foundation Trust
Nuffield Orthopedic Centre Windmill Road Headington
Health Technology Assessment Programme
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
Funding Body Subtype
NIHR Oxford Biomedical Research Centre
NIHR Biomedical Research Centre, Oxford, OxBRC
Funding Body Type
private sector organisation
Funding Body Subtype
Research institutes and centers
Results and Publications
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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)