Condition category
Musculoskeletal Diseases
Date applied
22/06/2007
Date assigned
29/06/2007
Last edited
16/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Cushla Cooper

ORCID ID

Contact details

Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 737643
cushla.cooper@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 05/47/02; Version 4, 25/08/10

Study information

Scientific title

Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair

Acronym

UKUFF

Study hypothesis

Current 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

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)

Study design

Parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient 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

Condition

Musculoskeletal Diseases

Intervention

Current 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The UKUFF Questionnaire at 24 months after entry into study.

Secondary outcome measures

Resource use measures including use and cost of health services.

Overall trial start date

01/07/2007

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

As of 21/10/10: 270 (at time of registration: 690)

Participant exclusion criteria

1. 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

Recruitment start date

01/07/2007

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Windmill Road
Oxford
OX3 7LD
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom
+44 1865 743004
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 surgeon questionnaire results in: http://www.ncbi.nlm.nih.gov/pubmed/23145113
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24845913
2015 complete study results in http://www.ncbi.nlm.nih.gov/pubmed/26463717

Publication citations

  1. Surgeon questionnaire results

    Cook JA, Ramsay CR, Carr AJ, Rees JL, , A questionnaire elicitation of surgeons' belief about learning within a surgical trial., PLoS ONE, 2012, 7, 11, e49178, doi: 10.1371/journal.pone.0049178.

  2. Protocol

    Carr AJ, Rees JL, Ramsay CR, Fitzpatrick R, Gray A, Moser J, Dawson J, Bruhn H, Cooper CD, Beard DJ, Campbell MK, Protocol for the United Kingdom Rotator Cuff Study (UKUFF): a randomised controlled trial of open and arthroscopic rotator cuff repair., Bone Joint Res, 2014, 3, 5, 155-160, doi: 10.1302/2046-3758.35.2000270.

Additional files

Editorial Notes

16/10/2015: Added publication reference.