Clinical trial 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 - Pilot Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: carpometacarpal joints
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subsidence of CMC joint
timeFrame: 6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary outcomes:
measure: EQ-5D Health Questionnaire Score
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: DASH questionnaire score
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Grip strength as measured by dynamometer
timeFrame: Baseline, 3 months, 6 months, 1 year, 2 years
measure: Pinch strength as measured by dynamometer
timeFrame: Baseline, 3 months, 6 months, 1 year, 2 years
measure: Opposition as measured by goniometer
timeFrame: Baseline, 3 months, 6 months, 1 year, 2 years
measure: Radial abduction as measured by goniometer
timeFrame: Baseline, 3 months, 6 months, 1 year, 2 years
measure: Palmar abduction as measured by goniometer
timeFrame: Baseline, 3 months, 6 months, 1 year, 2 years
measure: Pain score on the visual analogue scale
timeFrame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Other outcomes:
measure: Number of participants with Adverse Events
timeFrame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
Study officials:
References: