Osteoarthritis Clinical Trial
Official title:
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
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
This study will be a prospective randomized trial done in a single academic center. The
patients who meet the inclusion criteria and agree to participate in the trial will be
scheduled for a first CMC joint procedure. The procedure, standard LRTI or LRTI with a
biotenodesis screw, will be allocated in a randomized fashion in the operating room using a
sealed opaque envelope. After the surgery the patient will be placed in a spica splint for
1-2 weeks. Following suture removal, a thumb spica cast will be applied for immobilization
for a total of 6 weeks of post-operative immobilisation.
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.
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