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NCT03722537 | SUSPENDED | Basal Joint Arthritis


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

Columbia University

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

NA

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
Primary Purpose : TREATMENT
Official Title : Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
Actual Study Start Date : 2019-11-14
Estimated Primary Completion Date : 2026-03
Estimated Study Completion Date : 2026-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

Location Details

NCT03722537


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Locations


Not yet recruiting

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032

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