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

This study is currently recruiting participants.
Verified August 2012 by William Beaumont Hospitals
Sponsor:
Collaborator:
Musculoskeletal Transplant Foundation
Information provided by (Responsible Party):
Paul Fortin, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01673347
First received: August 14, 2012
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
 Biological: Meniscal Allograft
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • TO PERFORM A SCIENTIFIC EVALUATIONOF THE EFFICACY, IN TERMS OF DECREASED PAIN AND INCREASED FUNCTIONALITY FOR THE PATIENT [ Time Frame: 1-2 WEEKS, 6WKS, 3MO, 6MO. IYR, 2YR, 3YR, 4YR, 5YR ] [ Designated as safety issue: Yes ]
    VAS, FAOS


Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673347

Contacts
Contact: PAUL FORTIN, MD 248-280-8550

Locations
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: PAUL FORTIN, MD     248-280-8550        
Sponsors and Collaborators
Paul Fortin, MD
Musculoskeletal Transplant Foundation
Investigators
Principal Investigator: PAUL FORTIN, MD WILLIAM BEAUMONT HOSPITAL ROYAL OAK
  More Information

Additional Information:
Beaumont Hospital  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Paul Fortin, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01673347     History of Changes
Other Study ID Numbers: 2010-182, ISO 13485
Study First Received: August 14, 2012
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013