UnknownNot Applicable

CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

United States217 participantsStarted 2017-01-23

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change overtime of Olerud and Molander Ankle Score (OMAS)

Timeframe: 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

Timeframe: 6 months & 12 months

Trial details

NCT IDNCT02688855

SponsorEncore Medical, L.P.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03

Contact for this trial

Akujuobi Udu, MS

248-914-0150 akujuobi.udu@djoglobal.com

View on ClinicalTrials.gov More Bimalleolar Ankle Fractures trials