Osteoarthritis
Conditions
Keywords
allograft, great toe
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.
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.
Interventions
BIOLOGICALMeniscal Allograft
Meniscal allograft
Sponsors
Musculoskeletal Transplant Foundation
Paul Fortin, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Allograft Stability | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain | 3-months postoperative | Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain |
| Range of Motion Plantarflexion | 3-months postoperative | Range of Motion Plantarflexion |
| Range of Motion Dorsiflexion | 3-months postoperative | Range of Motion Dorsiflexion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MENISCAL ALLOGRAFT The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.
Meniscal Allograft: Meniscal allograft | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | failure of allograft | 7 |
Baseline characteristics
| Characteristic | MENISCAL ALLOGRAFT |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 7.12 |
| BMI | 25.27 kg/m2 STANDARD_DEVIATION 4.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 7 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
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.
Time frame: 5-years postoperative
Population: Study terminated prior to 5-year endpoint, no participants evaluated
| Arm | Measure | Value |
|---|---|---|
| MENISCAL ALLOGRAFT | Allograft Stability | 0 |
Secondary
Pain
Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time frame: 3-months postoperative
Population: 17 participants available to analyze at 3 months due to early allograft failure in 7 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MENISCAL ALLOGRAFT | Pain | 2.65 units on a scale | Standard Deviation 2.13 |
Secondary
Range of Motion Dorsiflexion
Range of Motion Dorsiflexion
Time frame: 3-months postoperative
Population: 17 participants available to analyze at 3 months due to early allograft failure in 7 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MENISCAL ALLOGRAFT | Range of Motion Dorsiflexion | 40 degrees | Standard Deviation 15.86 |
Secondary
Range of Motion Plantarflexion
Range of Motion Plantarflexion
Time frame: 3-months postoperative
Population: 17 participants available to analyze at 3 months due to early allograft failure in 7 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MENISCAL ALLOGRAFT | Range of Motion Plantarflexion | 20 degrees | Standard Deviation 8.13 |