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

Andrew Trenholm

Status: Completed

Conditions: Osteoarthritis

Treatments: Procedure: LRTI; Device: Biotenodesis Screw

Study type: Interventional

Funder types: Other

Identifiers

NCT02352610

2015-239

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

LRTI without a Biotenodesis Screw

Active Comparator group

Description:

Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw

Treatment:

Procedure: LRTI

LRTI with Biotenodesis Screw

Active Comparator group

Description:

Ligament Reconstruction Tendon Interposition with Biotenodesis Screw

Treatment:

Device: Biotenodesis Screw

Procedure: LRTI