Bimalleolar Ankle FracturesNCT02688855
CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
A study testing Active Combined Magnetic Field OL1000 Bone Growth Stimulator in people with Bimalleolar Ankle Fractures, run by Encore Medical, L.P. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bimalleolar Ankle Fractures
- What is being tested?
- Active Combined Magnetic Field OL1000 Bone Growth Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 9 sitesUnited States
- Study dates
- 23 Jan 2017to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Minton Cooper, MD, 434-243-0256, MTC2D@hscmail.mcc.virginia.edu
Minton Cooper, MD
- Recruiting
Orthopaedic Associates of South Broward, P.A.
Hollywood, Florida, 33021
Steven Steinlauf, MD, 954-854-3463, info@oasb.net
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90069
Charles Moon, MD, 310-423-1620, Goran.Stankovic@cshs.org
- Recruiting
Rutgers Biomedical Health Sciences
Newark, New Jersey, 07103
Sheldon Lin, MD, 973-972-2184, emo65@njms.rutgers.edu
- Withdrawn
OrlandoHealth
Orlando, Florida, 32828
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Daniel Farber, MD, 215-829-3613, Aliaksei.Basatski@uphs.upenn.edu
- Recruiting
University of Rochester
Rochester, New York, 14627
Kyle Judd, MD, 585-276-7790, Kyle_Judd@URMC.Rochester.edu
- Recruiting
William Beaumont Hospital
Royal Oak, Michigan, 48073
Zachary Vaupel, MD, 248-551-0194, Kelly.Slade@beaumont.org
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Daniel Latt, MD, 520-626-5472, mgordon@email.arizona.edu
About this study
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 Fractures
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
- Bimalleolar Ankle Fractures
- Being tested
- Active Combined Magnetic Field OL1000 Bone Growth Stimulator, Sham Combined Magnetic Field OL1000 Bone Growth Stimulator
- Keywords
- Bone Growth Stimulator, Ankle Fracture
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Combined Magnetic Field OL1000 Bone Growth StimulatorDevice
Also called CMF OL1000
Active CMF OL1000 Device
Sham Combined Magnetic Field OL1000 Bone Growth StimulatorDevice
Also called CMF OL1000
Sham CMF OL1000
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group | Experimental | Standard Rigid Fixation + Active OL1000 device Receives: Device: Active Combined Magnetic Field OL1000 Bone Growth Stimulator |
| Control Group | Sham comparator | Standard Rigid Fixation + Sham OL1000 device Receives: Device: Sham Combined Magnetic Field OL1000 Bone Growth Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change overtime of Olerud and Molander Ankle Score (OMAS)
Measured: 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
Measured: 6 months & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start23 Jan 2017
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bimalleolar Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688855
- Sponsor's protocol ID
- PS-607
- Status last verified
- Dec 2021
- First submitted
- 18 Feb 2016
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Phillips WA, Schwartz HS, Keller CS, Woodward HR, Rudd WS, Spiegel PG, Laros GS. A prospective, randomized study of the management of severe ankle fractures. J Bone Joint Surg Am. 1985 Jan;67(1):67-78.
PubMed 3881447Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.
PubMed 6437370
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Fractures
- ClinicalTrials.gov ID
- NCT02688855
- Acronym / sponsor ID
- PS-607
- Conditions
- Bimalleolar Ankle Fractures
- Keywords
- Bone Growth Stimulator, Ankle Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Group | Experimental | Device: Active Combined Magnetic Field OL1000 Bone Growth StimulatorStandard Rigid Fixation + Active OL1000 device |
| Control Group | Sham comparator | Device: Sham Combined Magnetic Field OL1000 Bone Growth StimulatorStandard Rigid Fixation + Sham OL1000 device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Combined Magnetic Field OL1000 Bone Growth StimulatorAlso: CMF OL1000Active CMF OL1000 Device | Device | Investigational Group |
| Sham Combined Magnetic Field OL1000 Bone Growth StimulatorAlso: CMF OL1000Sham CMF OL1000 | Device | Control Group |
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Results publication: PubMed 3881447Phillips WA, Schwartz HS, Keller CS, Woodward HR, Rudd WS, Spiegel PG, Laros GS. A prospective, randomized study of the management of severe ankle fractures. J Bone Joint Surg Am. 1985 Jan;67(1):67-78.
- Results publication: PubMed 6437370Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Combined Magnetic Field OL1000 Bone Growth Stimulator in people with Bimalleolar Ankle Fractures, run by Encore Medical, L.P. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akujuobi Udu, MS (248-914-0150, akujuobi.udu@djoglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change overtime of Olerud and Molander Ankle Score (OMAS) (time frame: 6 weeks, 8 weeks, 10 weeks and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02688855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.