A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) With an Interference Screw for Thumb Carpometacarpal Arthritis - Pilot Study
NCT ID: NCT02352610
Last Updated: 2018-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2015-03-31
2018-04-30
Brief Summary
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Detailed Description
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The potential population for this study will include all patients with first carpometacarpal joint arthritis that have failed a conservative treatment. The primary outcome will be the thumb subsidence measured as the percentage of trapezial height, which correlates with stability. Subsidence will be measured on stress x-ray under a standard pinch load. Secondary outcomes will be function measured in 4 different ways: the range of motion compared to the contralateral side, pinch and grip strength compared to the other side, the Disabilities of the Arm Shoulder and Hand (DASH) score and the pain score on a visual analogue scale.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LRTI without a Biotenodesis Screw
Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw
LRTI
LRTI with Biotenodesis Screw
Ligament Reconstruction Tendon Interposition with Biotenodesis Screw
LRTI
Biotenodesis Screw
Interventions
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LRTI
Biotenodesis Screw
Eligibility Criteria
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Inclusion Criteria
* Patient \>age 18
* Able to read and understand English
* Available for 2 year follow up
Exclusion Criteria
* Active infection in the first CMC joint
* Concomitant neuropathy
* Previous surgical procedure on the thumb
* Active or status post CRPS
* Severe ¨Z ¨deformity that requires palmar plate advancement
* Unwilling to participate in a research project
* Contralateral first CMC joint surgery
18 Years
ALL
No
Sponsors
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Andrew Trenholm
OTHER
Responsible Party
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Andrew Trenholm
Orthopaedic Surgeon
Locations
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Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Countries
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Other Identifiers
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2015-239
Identifier Type: -
Identifier Source: org_study_id
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