Condition category
Injury, Occupational Diseases, Poisoning
Date applied
22/06/2020
Date assigned
02/07/2020
Last edited
02/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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
procure@ndorms.ox.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Naomi Merritt

ORCID ID

Contact details

The Botnar Research Centre
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
+44 (0)1865227684
procure@ndorms.ox.ac.uk

Type

Scientific

Additional contact

Mrs Naomi Merritt

ORCID ID

Contact details

The Botnar Research Centre
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
+44 (0)1865227684
procure@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

HTA - NIHR128043, PID15009

Study information

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

Acronym

PRoCuRe

Study hypothesis

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

Submission pending

Study design

Multi-centre parallel patient blinded two-arm randomised controlled trial with integrated QuinteT Recruitment Intervention (QRI) to support recruitment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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

01/01/2020

Overall trial end date

30/09/2027

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

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

01/09/2020

Recruitment end date

01/09/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nuffield Orthopedic Centre, Oxford University Hospitals NHS Foundation Trust
Nuffield Orthopedic Centre Windmill Road Headington
Oxford
OX3 7LD
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Joint Research Office
1st Floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
United Kingdom
+44 (0)1865 289885
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

NIHR Oxford Biomedical Research Centre

Alternative name(s)

NIHR Biomedical Research Centre, Oxford, OxBRC

Funding Body Type

private sector organisation

Funding Body Subtype

Research institutes and centers

Location

United Kingdom

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

01/11/2028

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/06/2020: Trial's existence confirmed by the NIHR.