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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by William Beaumont Hospitals.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 18, 2014