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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LRTI without a Biotenodesis Screw | Active Comparator | Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw |
|
| LRTI with Biotenodesis Screw | Active Comparator | Ligament Reconstruction Tendon Interposition with Biotenodesis Screw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LRTI | Procedure |
| ||
| Biotenodesis Screw |
| Measure | Description | Time Frame |
|---|---|---|
| Subsidence of CMC joint | Measurement of trapezial height as a percentage of pre-operative height | 6 weeks, 3 months, 6 months, 1 year, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D Health Questionnaire Score | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | |
| DASH questionnaire score | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H3A7 | Canada |
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| Device |
|
| Grip strength as measured by dynamometer |
| Baseline, 3 months, 6 months, 1 year, 2 years |
| Pinch strength as measured by dynamometer | Baseline, 3 months, 6 months, 1 year, 2 years |
| Opposition as measured by goniometer | thumb range of motion | Baseline, 3 months, 6 months, 1 year, 2 years |
| Radial abduction as measured by goniometer | thumb range of motion | Baseline, 3 months, 6 months, 1 year, 2 years |
| Palmar abduction as measured by goniometer | thumb range of motion | Baseline, 3 months, 6 months, 1 year, 2 years |
| Pain score on the visual analogue scale | visual analogue scale | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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