Clinical Trial: CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
Brief 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.
Detailed Summary:
Sponsor: Encore Medical, L.P.
Current Primary Outcome:
- Change overtime of Olerud and Molander Ankle Score (OMAS) [ Time Frame: 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 [ Time Frame: 6 months & 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Encore Medical, L.P.
Dates:
Date Received: February 18, 2016
Date Started: January 23, 2017
Date Completion: December 2018
Last Updated: February 6, 2017
Last Verified: February 2017
