Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

Columbia University

Status: Suspended

Conditions: Basal Joint Arthritis

Treatments: Procedure: Ligament Reconstruction Tendon Interposition; Procedure: Osteochondral Allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT03722537

AAAS2615

Details and patient eligibility

About

This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively.

Full description

Basal joint arthritis of the thumb is a common condition associated with considerable morbidity. Many non-operative and operative treatments have been described, but few multicenter prospective evidence based trials exist comparing standard treatments. This continuing search for consensus and improvement of best clinical practice has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Operative treatments range from osteotomy, partial or complete trapeziectomy with or without reconstruction of the ligaments, tendon interposition to arthrodesis, however the functional outcome varies. Allograft has been previously described in joint replacement / prosthetic implantation surgery in other areas of the body, however not in the thumb. The purpose of this study is to investigate using osteochondral allograft in the surgical intervention phase of treatment for patients with basal joint arthritis.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Indicated for operative management of basal joint arthritis

Exclusion criteria

• Pregnant women/fetuses/neonates, prisoners
• Previously operated on for treatment of basal joint arthritis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Ligament Reconstruction Tendon Interposition (LRTI)

Active Comparator group

Description:

Selected randomly, 100 patients will receive this treatment. During the LRTI (standard of care procedure), the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together.

Treatment:

Procedure: Ligament Reconstruction Tendon Interposition

Osteochondral Allograft

Experimental group

Description:

Selected randomly,100 patients will receive this treatment. In this procedure, the arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface, known as the 'Cartibend©' .

Treatment:

Procedure: Osteochondral Allograft