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Tissue Graft

Osteochondral Allograft for Arthritis

N/A

Recruiting

Led By Melvin P Rosenwasser, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Indicated for operative management of basal joint arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-operatively

Awards & highlights

No Placebo-Only Group

Summary

"This trial is comparing the usual surgery for thumb base treatment to a newer surgery involving inserting donated bone and cartilage at the base of the thumb. Patients will be monitored for 1, 3,

Who is the study for?

This trial is for adults over 18 who need surgery to manage basal joint arthritis, which affects the base of the thumb. Participants must be suitable candidates for surgical intervention.

What is being tested?

The study compares traditional ligament reconstruction and tendon interposition (LRTI) surgery with a newer procedure that uses an osteochondral allograft implant at the thumb's base. Progress is monitored up to one year after surgery.

What are the potential side effects?

Potential side effects may include pain, swelling, infection at the surgical site, stiffness or loss of movement in the thumb, graft failure or rejection, and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am recommended surgery for thumb arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Score on the Thumb Disability Exam (TDX)

Visual Analog Scale for pain (VAS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Osteochondral AllograftExperimental Treatment1 Intervention

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©' .

Group II: Ligament Reconstruction Tendon Interposition (LRTI)Active Control1 Intervention

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.

0 / 2Eligibility criteria met