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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02688855

Enrollment

217

Registered

2016-02-23

Start date

2017-01-23

Completion date

2022-06-30

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bimalleolar Ankle Fractures

Keywords

Bone Growth Stimulator, Ankle Fracture

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.

Interventions

DEVICEActive Combined Magnetic Field OL1000 Bone Growth Stimulator

Active CMF OL1000 Device

DEVICESham Combined Magnetic Field OL1000 Bone Growth Stimulator

Sham CMF OL1000

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change overtime of Olerud and Molander Ankle Score (OMAS)	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	6 months & 12 months

Countries

United States

Contacts

Primary ContactAkujuobi Udu, MS

akujuobi.udu@djoglobal.com248-914-0150

Backup ContactJessica Knowlton, MS

jessica.knowlton@djoglobal.com732-666-7550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026