Osteoarthritis
Conditions
Keywords
carpometacarpal joints
Brief summary
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
Detailed description
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.
Interventions
PROCEDURELRTI
DEVICEBiotenodesis Screw
Sponsors
Andrew Trenholm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First CMC primary osteoarthritis refractory to conservative treatment * Patient \>age 18 * Able to read and understand English * Available for 2 year follow up
Exclusion criteria
* Inflammatory Arthritis * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subsidence of CMC joint | 6 weeks, 3 months, 6 months, 1 year, 2 years | Measurement of trapezial height as a percentage of pre-operative height |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Radial abduction as measured by goniometer | Baseline, 3 months, 6 months, 1 year, 2 years | thumb range of motion |
| Palmar abduction as measured by goniometer | Baseline, 3 months, 6 months, 1 year, 2 years | thumb range of motion |
| Pain score on the visual analogue scale | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years | visual analogue scale |
| Opposition as measured by goniometer | Baseline, 3 months, 6 months, 1 year, 2 years | thumb range of motion |
Other
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
Countries
Canada
Outcome results
None listed