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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01673347
Recruitment Status : Completed
First Posted : August 28, 2012
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Musculoskeletal Transplant Foundation
Information provided by (Responsible Party):
Paul Fortin, MD, William Beaumont Hospitals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: Meniscal Allograft Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : September 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain [ Time Frame: 3-months postoperative ]
    Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

  2. Range of Motion Plantarflexion [ Time Frame: 3-months postoperative ]
    Range of Motion Plantarflexion

  3. Range of Motion Dorsiflexion [ Time Frame: 3-months postoperative ]
    Range of Motion Dorsiflexion


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673347


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

Publications:
COLE BJ, CARTER TR, RODEO SA,

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Responsible Party: Paul Fortin, MD, Orthopedic Surgeon, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01673347    
Other Study ID Numbers: 2010-182
ISO 13485 ( Other Identifier: MUSCULOSKELETAL TRANSPLANT FOUNDATION )
First Posted: August 28, 2012    Key Record Dates
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Fortin, MD, William Beaumont Hospitals:
allograft
great toe
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases