Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192128859
Study information
Scientific title
Acronym
Study hypothesis
The purpose of the study will be to see whether preserving the flexor sheath during decompression of the carpal tunnel improves recovery.
We believe that by trying to keep an extra piece of tissue beneath the median nerve will provide a smooth gliding surface and aid recovery in time and function.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Nervous System Diseases: Carpal tunnel syndrome (CTS)
Intervention
Randomised Controlled Trial to see whether preserving the flexor sheath during decompression of the carpal tunnel improves recovery.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Grip strengths
2. scar pain
3. Patient Evaluation Measure score
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/07/2003
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. 100 affected patients (50 patients and 50 control patients)
2. male or female
3. aged 20-70
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
30/07/2003
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Queen's Medical Centre University Hospital NHS Trust (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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17079401
Publication citations
-
Results
Forward DP, Singh AK, Lawrence TM, Sithole JS, Davis TR, Oni JA, Preservation of the ulnar bursa within the carpal tunnel: does it improve the outcome of carpal tunnel surgery? A randomized, controlled trial., J Bone Joint Surg Am, 2006, 88, 11, 2432-2438, doi: 10.2106/JBJS.F.00013.