Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Osteochondral Allograft, Ligament Reconstruction Tendon Interposition.
- Who it may be relevant to
- Registry conditions: Basal Joint Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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. - Procedure 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 measures
- Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [Time frame: Up to 1 year post-operatively]
Secondary outcome measures (2)
- Score on the Thumb Disability Exam (TDX) [Time frame: Up to 1 year post-operatively]
- Visual Analog Scale for pain (VAS) [Time frame: Up to 1 year post-operatively]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Columbia University Irving Medical Center — New York
Identifiers
NCT: NCT03722537 · AAAS2615