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The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization. The initiation of the adjunctive treatment is to begin within 11 days of surgical stabilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Group | Experimental | Standard Rigid Fixation + Active OL1000 device |
|
| Control Group | Sham Comparator | Standard Rigid Fixation + Sham OL1000 device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Combined Magnetic Field OL1000 Bone Growth Stimulator | Device | Active CMF OL1000 Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change overtime of Olerud and Molander Ankle Score (OMAS) | 6 weeks, 8 weeks, 10 weeks and 12 weeks | |
| Non-powered, composite safety endpoint consisting of: Joint Position Outcome Radiographic Failure and Repeat, Unplanned Surgery at the Operative Site and Device-Related Serious Adverse Events | 6 months & 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akujuobi Udu, MS | Contact | 248-914-0150 | akujuobi.udu@djoglobal.com | |
| Jessica Knowlton, MS | Contact | 732-666-7550 | jessica.knowlton@djoglobal.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3881447 | Result | Phillips WA, Schwartz HS, Keller CS, Woodward HR, Rudd WS, Spiegel PG, Laros GS. A prospective, randomized study of the management of severe ankle fractures. J Bone Joint Surg Am. 1985 Jan;67(1):67-78. | |
| 6437370 | Result | Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Sham Combined Magnetic Field OL1000 Bone Growth Stimulator | Device | Sham CMF OL1000 |
|
|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90069 | United States |
|
| Orthopaedic Associates of South Broward, P.A. | Recruiting | Hollywood | Florida | 33021 | United States |
|
| OrlandoHealth | Withdrawn | Orlando | Florida | 32828 | United States |
| William Beaumont Hospital | Recruiting | Royal Oak | Michigan | 48073 | United States |
|
| Rutgers Biomedical Health Sciences | Recruiting | Newark | New Jersey | 07103 | United States |
|
| University of Rochester | Recruiting | Rochester | New York | 14627 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
|
| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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