Trials / Unknown
UnknownNCT02688855
CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 217 (estimated)
- Sponsor
- Encore Medical, L.P. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Active Combined Magnetic Field OL1000 Bone Growth Stimulator | Active CMF OL1000 Device |
| DEVICE | Sham Combined Magnetic Field OL1000 Bone Growth Stimulator | Sham CMF OL1000 |
Timeline
- Start date
- 2017-01-23
- Primary completion
- 2022-03-01
- Completion
- 2022-06-01
- First posted
- 2016-02-23
- Last updated
- 2022-03-21
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02688855. Inclusion in this directory is not an endorsement.