Odontoid Fracture Type IINCT02281994
Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields
A study testing Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD in people with Odontoid Fracture Type II, run by Orthofix Inc..
Trial summary
The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing, compared with standard conservative care, in subjects 50 years of age and over diagnosed with Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Odontoid Fracture Type II
- What is being tested?
- Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2019
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 50 years of age or older at the time of consent
- Subject must have radiographic evidence (x-ray , MRI and CT scan) of a Type II odontoid fracture
- Subject must have MRI evidence that the fracture occurred within 30 days of study enrollment
- Subject must have VAS neck pain score of greater than 4 (>4)
- Subject must have radiographic evidence that the fracture is displaced ≤ 5 mm in any direction and/or have a fracture gap of ≤ 3 mm due to angulation
- Subject must use a rigid cervical collar (Miami J, Philadelphia or Aspen) for a minimum of three months post-injury
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- Subject must have a DEXA scan within 6 months prior to enrollment (can be done within one week of baseline visit)
- Subject must be willing and able to follow all study procedures and return for all study visits
- Subject must be willing to sign an Informed Consent Document
Who cannot join
- Subject has undergone systematic administration, within 30 days prior to the fracture, of any type of corticosteroid, antineoplastic, immunostimulation or immunosuppressive agents
- Subject is on chronic anticoagulation, or has a bleeding disorder
- Subject is pregnant, nursing or plans to become pregnant during the study
- Subject has a chronic Type II odontoid fracture that occurred more than 21 days prior to enrollment
- Subject has a Type II odontoid fracture displaced >5 mm
- Subject has a mental or physical condition that would prevent him from complying with the study protocol, including the physician obtaining an accurate neurologic exam
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- Subject was recommended for surgery to treat the fracture but subject refused surgery
- Subject is a prisoner
- Subject has participated in another clinical trial within the last 90 days
About this study
Official title: Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim®) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process
The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing, compared with standard conservative care, in subjects 50 years of age and over diagnosed with Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Subjects will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and CT scan. Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo control) to either the active or control device for 4 hours a day for 6 months. X-rays will be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process, with flexion-extension x-rays collected at 3, 6 and 12 months. A CT scan will be performed at 6 months to confirm healing. Quality of Life measures (SF-36, VAS neck pain scale, NDI) will be collected at all visits (6 weeks, 3, 6 and 12 months). Study subjects will receive either an active Orthofix Cervical-Stim Model 2205OD or an inactive (placebo) Orthofix Cervical-Stim Model 2205OD device.
- Conditions
- Odontoid Fracture Type II
- Being tested
- Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD
- Keywords
- PEMF, odontoid fracture, IDE, prospective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205ODDevice
Active devices emit PEMF signal; control devices do not emit PEMF signal.
| Study group | Role | What they receive |
|---|---|---|
| Active PEMF | Active comparator | Active device emits Pulsed Electromagnetic Field (PEMF) Receives: Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD |
| Control/no PEMF | Placebo comparator | control/placebo device does not emit Pulsed Electromagnetic Field (PEMF) Receives: Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time of VAS pain
Measured: Baseline, 6 week, 3 month, 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontoid Fracture Type IIStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Arnold, MD, Principal investigator, The University of Kansas HospitalWellington Hsu, MD, Principal investigator, Northwestern UniversityZachary Ray, MD, Principal investigator, Washington University School of MedicineKhalid Abbed, MD, Principal investigator, Yale UniversityJoshua Ammerman, MD, Principal investigator, Washington Neurosurgical AssociatesJung Yoo, MD, Principal investigator, Oregon Health and Science UniversityKelly Banagan, MD, Principal investigator, University of Maryland, College ParkKee Kim, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281994
- Sponsor's protocol ID
- CP-1402ODFX
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2014
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim®) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process
- ClinicalTrials.gov ID
- NCT02281994
- Acronym / sponsor ID
- CP-1402ODFX
- Conditions
- Odontoid Fracture Type II
- Keywords
- PEMF, odontoid fracture, IDE, prospective
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 4 Nov 2014 (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 hypothesis of this study is that PEMF treatment will improve odontoid fracture healing, compared with standard conservative care, in subjects 50 years of age and over diagnosed with Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Subjects will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and CT scan. Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo control) to either the active or control device for 4 hours a day for 6 months. X-rays will be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process, with flexion-extension x-rays collected at 3, 6 and 12 months. A CT scan will be performed at 6 months to confirm healing. Quality of Life measures (SF-36, VAS neck pain scale, NDI) will be collected at all visits (6 weeks, 3, 6 and 12 months). Study subjects will receive either an active Orthofix Cervical-Stim Model 2205OD or an inactive (placebo) Orthofix Cervical-Stim Model 2205OD device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PEMF | Active comparator | Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205ODActive device emits Pulsed Electromagnetic Field (PEMF) |
| Control/no PEMF | Placebo comparator | Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205ODcontrol/placebo device does not emit Pulsed Electromagnetic Field (PEMF) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be 50 years of age or older at the time of consent
- Subject must have radiographic evidence (x-ray , MRI and CT scan) of a Type II odontoid fracture
- Subject must have MRI evidence that the fracture occurred within 30 days of study enrollment
- Subject must have VAS neck pain score of greater than 4 (>4)
- Subject must have radiographic evidence that the fracture is displaced ≤ 5 mm in any direction and/or have a fracture gap of ≤ 3 mm due to angulation
Key exclusion criteria (9 listed)
- Subject has undergone systematic administration, within 30 days prior to the fracture, of any type of corticosteroid, antineoplastic, immunostimulation or immunosuppressive agents
- Subject is on chronic anticoagulation, or has a bleeding disorder
- Subject is pregnant, nursing or plans to become pregnant during the study
- Subject has a chronic Type II odontoid fracture that occurred more than 21 days prior to enrollment
- Subject has a Type II odontoid fracture displaced >5 mm
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 |
|---|---|---|
| Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205ODActive devices emit PEMF signal; control devices do not emit PEMF signal. | Device | Active PEMF, Control/no PEMF |
Primary outcome
Change over time of VAS pain
Time frame: Baseline, 6 week, 3 month, 6 month, 12 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
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.
Paul Arnold, MD principal investigator
The University of Kansas Hospital
Wellington Hsu, MD principal investigator
Northwestern University
Zachary Ray, MD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD in people with Odontoid Fracture Type II, run by Orthofix Inc..
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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change over time of VAS pain (time frame: Baseline, 6 week, 3 month, 6 month, 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2021.