ISRCTN ISRCTN97804283
DOI https://doi.org/10.1186/ISRCTN97804283
Secondary identifying numbers HTA 05/47/02; Version 4, 25/08/10
Submission date
22/06/2007
Registration date
29/06/2007
Last edited
05/12/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.ndorms.ox.ac.uk/clinicaltrials.php?trial=rotcuffsur

Study website

Contact information

Ms Cushla Cooper
Scientific

Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom

Phone +44 (0)1865 737643
Email cushla.cooper@ndorms.ox.ac.uk

Study information

Study designParallel-group randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Patient Information Sheet version 6 dated 19/01/2010 is available for download from https://viis.abdn.ac.uk/HSRU/UKUFF/Site/Public/DownloadPage.aspx
Scientific titleClinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair
Study acronymUKUFF
Study objectivesCurrent information as of 21/10/10:

Initial information at time of registration:
To assess the clinical and cost effectiveness of three treatments for rotator cuff tears - surgical (arthroscopic or open repair) versus non-surgical management.

Please note that as of 21/10/10 this record has been updated to reflect changes in the trial protocol from a 3-arm to a 2-arm trial. More details can be found in the relevant fields with the above update date. Please also note that the anticipated end date of the trial has been extended from 30/06/12 to 31/12/13.

More details at http://www.hta.ac.uk/project/1551.asp
Protocol available at http://www.hta.ac.uk/protocols/200500470002.pdf
Ethics approval(s)Current information as of 21/10/10:
Multi-centre Research Ethics Committee (MREC) approved on the 15th of April 2010 (ref: 07/Q1606/49)

Initial information at time of registration:
Multi-centre Research Ethics Committee (MREC) approved on the 12th of June 2007 (ref: 07/Q1606/49)
Health condition(s) or problem(s) studiedMusculoskeletal Diseases
InterventionCurrent information as of 21/10/10:
Each participant will be randomised to one of the following arms:
Arm 1 - Open/mini-open surgery
Arm 2 - Arthroscopic surgery

Initial information at time of registration
Each participant will be randomised to one of the following arms:
Arm 1: Arthroscopic surgery
Arm 2: Open surgery
Arm 3: “Rest then Exercise” Programme
Intervention typeOther
Primary outcome measureThe UKUFF Questionnaire at 24 months after entry into study.
Secondary outcome measuresResource use measures including use and cost of health services.
Overall study start date01/07/2007
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsAs of 21/10/10: 270 (at time of registration: 690)
Key inclusion criteria1. Aged 50 years or older
2. Suffer from degenerative rotator cuff tear
3. Have full thickness rotator cuff tear
4. Tear diagnosed using Magnetic Resonance Imaging (MRI) or ultrasound scan
5. Patient able to consent
Key exclusion criteria1. Previous surgery on affected shoulder
2. Dual shoulder pathology
3. Significant problems in other shoulder
4. Rheumatoid arthritis / systemic disease
5. Significant osteoarthritis problems
6. Significant neck problems
7. Cognitive impairment or language issues
Date of first enrolment01/07/2007
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Windmill Road
Oxford
OX3 7LD
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom

Phone +44 1865 743004
Email heather.house@admin.ox.ac.uk
Website http://www.admin.ox.ac.uk/rso
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article surgeon questionnaire results 01/06/2012 Yes No
Protocol article protocol 01/05/2014 Yes No
Results article complete study results 01/10/2015 Yes No

Editorial Notes

05/12/2017: internal review.
16/10/2015: Added publication reference.