Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H3A7, Canada
NCT Number: NCT02352610
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Halifax, Nova Scotia, B3H3A7, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 weeks, 3 months, 6 months, 1 year, 2 years
Measurement of trapezial height as a percentage of pre-operative height
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
thumb range of motion
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
thumb range of motion
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
thumb range of motion
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
visual analogue scale
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Andrew Trenholm
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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