Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
MTP
Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2017
CompletedResults Posted
Study results publicly available
May 23, 2017
CompletedMay 23, 2017
April 1, 2017
3.7 years
August 14, 2012
April 19, 2017
April 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Allograft Stability
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 Outcomes (3)
Pain
3-months postoperative
Range of Motion Plantarflexion
3-months postoperative
Range of Motion Dorsiflexion
3-months postoperative
Study Arms (1)
MENISCAL ALLOGRAFT
EXPERIMENTALThe meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.
Interventions
Meniscal allograft
Eligibility Criteria
You may qualify if:
- symptomatic of stage 3 osteoarthritis of the great toe
- symptoms recalcitrant to nonoperative management as determined clinically by the principal investigator
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paul Fortin, MDlead
- Musculoskeletal Transplant Foundationcollaborator
Study Sites (1)
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Related Publications (1)
COLE BJ, CARTER TR, RODEO SA,
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Allograft failure (dissolution) and obliteration of the MTP joint space found in 29% of subjects within 2 years of follow-up; therefore study was discontinued. No data collected for later time points.
Results Point of Contact
- Title
- Erin Baker, PhD
- Organization
- William Beaumont Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
PAUL FORTIN, MD
WILLIAM BEAUMONT HOSPITAL ROYAL OAK
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Orthopedic Surgeon
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 28, 2012
Study Start
September 1, 2010
Primary Completion
May 1, 2014
Study Completion
March 10, 2017
Last Updated
May 23, 2017
Results First Posted
May 23, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share