NCT02688855UnknownNot Applicable
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
Encore Medical, L.P.18 sites in 1 country217 target enrollmentStarted: January 23, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Encore Medical, L.P.
- Enrollment
- 217
- Locations
- 18
- Primary Endpoint
- Change overtime of Olerud and Molander Ankle Score (OMAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (18)
Loading locations...
Similar Trials
Completed
Phase 2
Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)Complicated Skin and Skin Structure InfectionsNCT01128530Furiex Pharmaceuticals, Inc161
Completed
Phase 1
Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation DiseasesOsteoarthritis of KneeNCT05081921Jagiellonian University192
Completed
Phase 1
Multiple Ascending Dose Study in Healthy VolunteersHealthyNCT02404922Concert Pharmaceuticals30
Completed
Phase 1
Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing BunionectomyPain, PostoperativeBunionNCT04826328Pacira Pharmaceuticals, Inc85
Completed
Phase 1
A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of AgeRespiratory Synctial VirusNCT02296463Novavax32