Bimalleolar Ankle Fractures Clinical Trial
Official title:
Prospective, Randomized, Double-Blinded, Controlled Multi-Center Clinical Trial Evaluating the Use of Non-Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
| NCT number | NCT02688855 |
| Other study ID # | PS-607 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 23, 2017 |
| Est. completion date | June 2022 |
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.
| Status | Recruiting |
| Enrollment | 217 |
| Est. completion date | June 2022 |
| Est. primary completion date | March 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | Inclusion Criteria: - Subject is diagnosed with an unstable, closed, isolated fracture of the ankle and underwent operative stabilization with plate(s) and/or screws (Weber Ankle Fracture Classification B and C) Exclusion Criteria: - Subject has an open fracture - Subject has any additional fractures of another bone besides the ankle fracture that is to be treated in the study including the contralateral ankle - Surgical stabilization was definitively performed with an external fixation system - Surgical stabilization was performed in such a manner that it will result in a fusion of the ankle joint - Malreduced Ankle as described by Phillips, et al 1985 JBJS - Surgical procedure included the use of osteoinductive materials in addition to rigid fixation - BMI = 40 kg/m2 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Virginia | Charlottesville | Virginia |
| United States | Orthopaedic Associates of South Broward, P.A. | Hollywood | Florida |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Rutgers Biomedical Health Sciences | Newark | New Jersey |
| United States | OrlandoHealth | Orlando | Florida |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University of Rochester | Rochester | New York |
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| United States | University of Arizona | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Encore Medical, L.P. |
United States,
Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg. 1984;103(3):190-4. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change overtime of Olerud and Molander Ankle Score (OMAS) | 6 weeks, 8 weeks, 10 weeks and 12 weeks | ||
| Primary | 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 |