Phase 3
N=24
Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01673347 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Allograft Stability — 0
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Meniscal Allograft (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paul Fortin, MD
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Allograft Stability |
— | — |
| SECONDARY Pain |
2.65 | — |
| SECONDARY Range of Motion Plantarflexion |
20 | — |
| SECONDARY Range of Motion Dorsiflexion |
40 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01673347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.