Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

Basal Joint Arthritis Clinical Trial

Official title:

Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03722537
• Other study ID #: AAAS2615
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2019
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: Melvin P Rosenwasser, MD
• Phone: 212-305-8036
• Email: mpr2[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Basal Joint Arthritis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Score on the Thumb Disability Exam (TDX)	The TDX is a questionnaire that measures changes in thumb function and pain, specifically for those with basal joint arthritis.The TDX is scored on a scale of 0 to 100, with a higher score indicating a greater degree of disability in the thumb.	Up to 1 year post-operatively
Secondary	Visual Analog Scale for pain (VAS)	The VAS is a validated technique that measures acute and chronic pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	Up to 1 year post-operatively