Study Stopped
Abandoned following local ethics review.
FCR or APL in LRTI - A Single Surgeon Randomized Controlled Trial
Flexor Carpi Radialis or Abductor Pollicis Longus in Ligament Reconstruction and Tendon Interposition - A Randomized Controlled Trial
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
We are investigating the use of the flexor carpi radialis and abductor pollicis longus tendons in the use of trapeziectomy and ligament reconstruction with tendon interposition. Previous studies have shown clinical equipoise, and we plan to do a randomized controlled trial to further assess.
Trial Health
Trial Health Score
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Started Aug 2016
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 5, 2016
August 1, 2016
Same day
September 1, 2015
August 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Disabilities of arm shoulder and hand questionnaire
questionnaire
5 years
Secondary Outcomes (2)
thumb range of motion
5 years
grip strength
5 years
Study Arms (2)
Flexor carpi radialis
ACTIVE COMPARATORThese patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the flexor carpi radialis tendon.
Abductor pollicis longus
ACTIVE COMPARATORThese patients will have their trapeziectomy with ligament reconstruction and tendon interposition using the abductor pollicis longus tendon.
Interventions
Ligament reconstruction with tendon interposition completed using the flexor carpi radialis tendon
Ligament reconstruction with tendon interposition completed using the abductor pollicis longus tendon
Eligibility Criteria
You may qualify if:
- patients with any grade of trapeziometacarpal joint osteoarthritis undergoing surgical correction with trapeziectomy and ligament reconstruction with tendon interposition
You may not qualify if:
- previous wrist surgery, inflammatory arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Vermeulen GM, Spekreijse KR, Slijper H, Feitz R, Hovius SE, Selles RW. Comparison of arthroplasties with or without bone tunnel creation for thumb basal joint arthritis: a randomized controlled trial. J Hand Surg Am. 2014 Sep;39(9):1692-8. doi: 10.1016/j.jhsa.2014.04.044. Epub 2014 Jun 10.
PMID: 24928359BACKGROUNDWajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4.
PMID: 25702783RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joseph P Corkum, MD,BEng
Nova Scotia Health Authority
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 1, 2015
First Posted
September 3, 2015
Study Start
August 1, 2016
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 5, 2016
Record last verified: 2016-08