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NCT03722537 | Not yet recruiting | Basal Joint Arthritis


Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
Sponsor:

Columbia University

Information provided by (Responsible Party):

Melvin Rosenwasser

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.

Condition or disease

Basal Joint Arthritis

Intervention/treatment

Osteochondral Allograft

Ligament Reconstruction Tendon Interposition

Phase

Not Applicable

Detailed 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.

Study Type : Interventional
Estimated Enrollment : 200 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
Actual Study Start Date : January 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024
Arm Intervention/treatment

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.

Procedure: Ligament Reconstruction Tendon Interposition

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©' .

Procedure: Osteochondral Allograft

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

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Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

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