Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe

Paul Fortin, MD1 site in 1 country24 target enrollmentSeptember 2010

ConditionsOsteoarthritis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Paul Fortin, MD
Enrollment: 24
Locations: 1
Primary Endpoint: Allograft Stability
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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. Patients will be evaluated for pain and range of motion at 3-months, 6-months, 1-year, 2-years, 3-years, 4-years, and 5-years postoperatively or until allograft failure. Stability of the allograft will be evaluated by the surgeon at these time points per radiographic imaging.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

March 10, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Paul Fortin, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Paul Fortin, MD

Orthopedic Surgeon

William Beaumont Hospitals

Eligibility Criteria

Inclusion Criteria

•symptomatic of stage 3 osteoarthritis of the great toe
•symptoms recalcitrant to nonoperative management as determined clinically by the principal investigator

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

Outcomes

Primary Outcomes

Allograft Stability

Time Frame: 5-years postoperative

Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.