Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment meniscal allograft
Phase phase 3
Sponsor Paul Fortin, MD
Collaborator Musculoskeletal Transplant Foundation
Start date September 2010
End date December 2015
Trial size 50 participants
Trial identifier NCT01673347, 2010-182, ISO 13485

Summary

Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.
meniscal allograft Musculoskeletal Transplant Foundation
Meniscal allograft

Primary Outcomes

Measure
TO PERFORM A SCIENTIFIC EVALUATIONOF THE EFFICACY, IN TERMS OF DECREASED PAIN AND INCREASED FUNCTIONALITY FOR THE PATIENT
time frame: 1-2 WEEKS, 6WKS, 3MO, 6MO. IYR, 2YR, 3YR, 4YR, 5YR

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - symptomatic of stage 3 osteoarthritis of the great toe - symptoms recalcitrant to nonoperative management as determined clinically by the pi Exclusion Criteria: - diabetes mellitus - kidney insufficiency - oa in the adjacent joints - malignancy with in the past 10 yrs - minors (< 18 yrs of age) - pregnant women and fetus - mentally disabled or cognitively impaired individuals

Additional Information

Official title Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
Principal investigator PAUL FORTIN, MD
Description A variety of surgical procedures have been developed for the treatment of MTP joint osteoarthritis of the great toe. Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by William Beaumont Hospitals.