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

Paul Fortin, MD

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Biological: Meniscal Allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT01673347

ISO 13485 (Other Identifier)

2010-182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

MENISCAL ALLOGRAFT

Experimental group

Description:

The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.

Treatment:

Biological: Meniscal Allograft