Recruiting

Standard Care vs. Osteochondral Allograft

Sponsor:

Columbia University

Code:

NCT03722537

Conditions

Basal Joint Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Osteochondral Allograft

Ligament Reconstruction Tendon Interposition

Study Details

Brief summary:

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.

Conditions

Basal Joint Arthritis

Study ID

NCT03722537

Start date

Nov 14, 2019

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ligament Reconstruction Tendon Interposition (LRTI)

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.

experimental: Osteochondral Allograft

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©' .

Interventions

Osteochondral Allograft

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.

Ligament Reconstruction Tendon Interposition

During the LRTI, 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.

Primary outcome measure

  • Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: Up to 1 year post-operatively ]

Central Contacts and Locations

Central contacts

Melvin P Rosenwasser, MD

212-305-8036mpr2@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Columbia University

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Allograft
  • Osteochondral Allograft
  • Arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-08.