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

NCT ID: NCT01673347

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2017-03-10

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MENISCAL ALLOGRAFT

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

Group Type: EXPERIMENTAL

Meniscal Allograft

Intervention Type: BIOLOGICAL

Meniscal allograft

Interventions

Meniscal Allograft

Meniscal allograft

Intervention Type: BIOLOGICAL

Other Intervention Names

Musculoskeletal Transplant Foundation; Meniscal transplant

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Musculoskeletal Transplant Foundation

OTHER

Sponsor Role: collaborator

Paul Fortin, MD

OTHER

Sponsor Role: lead

Responsible Party

Paul Fortin, MD

Orthopedic Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

PAUL FORTIN, MD

Role: PRINCIPAL_INVESTIGATOR

WILLIAM BEAUMONT HOSPITAL ROYAL OAK

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

References

COLE BJ, CARTER TR, RODEO SA,

Reference Type: BACKGROUND

Other Identifiers

ISO 13485

Identifier Type: OTHER

Identifier Source: secondary_id

2010-182

Identifier Type: -

Identifier Source: org_study_id