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
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
-
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.
-
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.