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

April 19, 2017 updated by: Paul Fortin, MD

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MENISCAL ALLOGRAFT
The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.
Biological: Meniscal Allograft
Meniscal allograft
Other Names:
  • Musculoskeletal Transplant Foundation
  • Meniscal transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5-years postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 3-months postoperative
Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
3-months postoperative
Range of Motion Plantarflexion
Time Frame: 3-months postoperative
Range of Motion Plantarflexion
3-months postoperative
Range of Motion Dorsiflexion
Time Frame: 3-months postoperative
Range of Motion Dorsiflexion
3-months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Fortin, MD

Collaborators

Musculoskeletal Transplant Foundation

Investigators

  • Principal Investigator: PAUL FORTIN, MD, William Beaumont Hospital Royal Oak

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • COLE BJ, CARTER TR, RODEO SA,

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2010

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

March 10, 2017

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (ESTIMATE)

August 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-182
  • ISO 13485 (OTHER: MUSCULOSKELETAL TRANSPLANT FOUNDATION)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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