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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe

Conditions
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Osteoarthritis

Intervention / Treatment
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* Biological: Meniscal Allograft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MENISCAL ALLOGRAFT<br>The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. | Biological: Meniscal Allograft<br>* Meniscal allograft<br>* Other names: Meniscal transplant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allograft, great toe