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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: Meniscal Allograft

• Registration Number: NCT01673347
• Lead Sponsor: Paul Fortin, MD

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-28
• Primary Completion: 2014-05
• Study Completion: 2017-03-10
• Status Verified: 2017-04
• Results First Submitted: 2017-04-19
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-05-23
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MENISCAL ALLOGRAFT	Meniscal Allograft	The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.

Primary Outcome Measures

Name	Time	Method
Allograft Stability	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.

Secondary Outcome Measures

Name	Time	Method
Range of Motion Plantarflexion	3-months postoperative	Range of Motion Plantarflexion
Pain	3-months postoperative	Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Range of Motion Dorsiflexion	3-months postoperative	Range of Motion Dorsiflexion

Trial Locations

Locations (1)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States