Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

NCT03722537 | Recruiting

• 1 other identifier: AAAS2615
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Allograft; Osteochondral Allograft; Arthritis

Outcome Measures

Primary Outcomes (1)

• Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

  The DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item questionnaire that includes 21 physical function items, 6 symptom items, and 3 social/role function items used to evaluate a patient's ability to perform upper extremity activities. Higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).

  Up to 1 year post-operatively

Secondary Outcomes (2)

• Score on the Thumb Disability Exam (TDX)

  Up to 1 year post-operatively

• Visual Analog Scale for pain (VAS)

  Up to 1 year post-operatively

Study Arms (2)

Ligament Reconstruction Tendon Interposition (LRTI)

ACTIVE COMPARATOR

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.

Procedure: Ligament Reconstruction Tendon Interposition

Osteochondral Allograft

EXPERIMENTAL

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©' .

Procedure: Osteochondral Allograft

Interventions

Osteochondral Allograft 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.

Also known as: Cartibend

Osteochondral Allograft

Ligament Reconstruction Tendon Interposition PROCEDURE

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.

Ligament Reconstruction Tendon Interposition (LRTI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Melvin P Rosenwasser, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melvin P Rosenwasser, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: November 14, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)