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| ID | Type | Description | Link |
|---|---|---|---|
| ISO 13485 | Other Identifier | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
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| Name | Class |
|---|---|
| Musculoskeletal Transplant Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MENISCAL ALLOGRAFT | Experimental | The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meniscal Allograft | Biological | Meniscal allograft |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PAUL FORTIN, MD | WILLIAM BEAUMONT HOSPITAL ROYAL OAK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | COLE BJ, CARTER TR, RODEO SA, |
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| ID | Title | Description |
|---|---|---|
| FG000 | MENISCAL ALLOGRAFT | The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. Meniscal Allograft: Meniscal allograft |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MENISCAL ALLOGRAFT | The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. Meniscal Allograft: Meniscal allograft |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study terminated prior to 5-year endpoint, no participants evaluated | Posted | 5-years postoperative |
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5 years postoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MENISCAL ALLOGRAFT | The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. Meniscal Allograft: Meniscal allograft |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allograft failure | Musculoskeletal and connective tissue disorders | Systematic Assessment | dissolution of allograft and obliteration of the MTP joint space |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Baker, PhD | William Beaumont Hospital | 248-551-1816 | erin.baker@beaumont.org |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 3-months postoperative |
| Range of Motion Dorsiflexion | Range of Motion Dorsiflexion | 3-months postoperative |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m2 |
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| Secondary | Pain | Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain | 17 participants available to analyze at 3 months due to early allograft failure in 7 participants | Posted | Mean | Standard Deviation | units on a scale | 3-months postoperative |
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|
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| Secondary | Range of Motion Plantarflexion | Range of Motion Plantarflexion | 17 participants available to analyze at 3 months due to early allograft failure in 7 participants | Posted | Mean | Standard Deviation | degrees | 3-months postoperative |
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| Secondary | Range of Motion Dorsiflexion | Range of Motion Dorsiflexion | 17 participants available to analyze at 3 months due to early allograft failure in 7 participants | Posted | Mean | Standard Deviation | degrees | 3-months postoperative |
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| 0 |
| 24 |
| 0 |
| 24 |
| 7 |
| 24 |
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