Nonunion of Fracture of Fifth MetatarsalNCT00586170
A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures
A study testing EBI Bone Healing System and Surgery in people with Nonunion of Fracture of Fifth Metatarsal, run by Zimmer Biomet at 2 sites in United States.
Trial summary
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonunion of Fracture of Fifth Metatarsal
- What is being tested?
- EBI Bone Healing System and Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has been diagnosed with a 5th metatarsal delayed or non-union.
- Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
- Male or female between ages of 18 and 75 years old, inclusive
Who cannot join
- Subject has synovial pseudarthrosis.
- Subject has a fracture gap of larger than 5mm as measured on CT Scan.
- Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
- If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
- Subject has an implanted unipolar pacemaker.
- Subjects who have previous malignant or connective tissue disorder.
- Subjects who use medication such as steroids or anticoagulants.
- Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Orthopedic Foot and Ankle Center
Columbus, Ohio, 43231
Neurological Institute of NJ
Newark, New Jersey, 07103
About this study
Official title: A Prospective, Randomized, Double-Blind Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fractures: Effect on Clinical Outcome and Growth Factor Synthesis
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
Read the detailed description
The investigators hypothesize:
- That treatment of 5th metatarsal non-union fracture with PEMF will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures.
- PEMF will stimulate increased expression of critical growth factors (i.e. BMP-2, BMP-4, BMP-7 as well as TGFb, IGF-1, FGF-2 and VEGF) at the non-union site to facilitate osseous healing of 5th metatarsal non-union fractures.
- Conditions
- Nonunion of Fracture of Fifth Metatarsal
- Being tested
- EBI Bone Healing System, Placebo Device, Surgery
- Keywords
- nonunion, fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBI Bone Healing SystemDevice
10 hours of treatment per day for up to 24 weeks
Placebo DeviceDevice
10 hours of treatment per day for up to 24 weeks
SurgeryProcedure or surgery
Open Reduction and Internal Fixation of the nonunion site
| Study group | Role | What they receive |
|---|---|---|
| EBI Bone Healing System + Surgery | Experimental | Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site. Receives: Device: EBI Bone Healing System; Procedure: Surgery |
| Placebo Device + Surgery | Placebo comparator | Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site. Receives: Device: Placebo Device; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Successful 5th Metatarsal Unions Achieved.
Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing.
Measured: 24 Weeks
Secondary outcomes (1)
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2011
- Study completionAug 2012
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonunion of Fracture of Fifth MetatarsalStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Evangelista, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586170
- Sponsor's protocol ID
- CS-027
- Status last verified
- Jun 2017
- First submitted
- 21 Dec 2007
- Last updated
- 21 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fractures: Effect on Clinical Outcome and Growth Factor Synthesis
- ClinicalTrials.gov ID
- NCT00586170
- Acronym / sponsor ID
- CS-027
- Conditions
- Nonunion of Fracture of Fifth Metatarsal
- Keywords
- nonunion, fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Posted 16 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
Detailed description
The investigators hypothesize:
- That treatment of 5th metatarsal non-union fracture with PEMF will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures.
- PEMF will stimulate increased expression of critical growth factors (i.e. BMP-2, BMP-4, BMP-7 as well as TGFb, IGF-1, FGF-2 and VEGF) at the non-union site to facilitate osseous healing of 5th metatarsal non-union fractures.
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 |
|---|---|---|
| EBI Bone Healing System + Surgery | Experimental | Device: EBI Bone Healing System, Procedure: SurgerySubject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site. |
| Placebo Device + Surgery | Placebo comparator | Device: Placebo Device, Procedure: SurgerySubject will be using a placebo device in conjunction with ORIF surgery of the nonunion site. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has been diagnosed with a 5th metatarsal delayed or non-union.
- Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
- Male or female between ages of 18 and 75 years old, inclusive
Key exclusion criteria (8 listed)
- Subject has synovial pseudarthrosis.
- Subject has a fracture gap of larger than 5mm as measured on CT Scan.
- Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
- If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
- Subject has an implanted unipolar pacemaker.
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 |
|---|---|---|
| EBI Bone Healing System10 hours of treatment per day for up to 24 weeks | Device | EBI Bone Healing System + Surgery |
| Placebo Device10 hours of treatment per day for up to 24 weeks | Device | Placebo Device + Surgery |
| SurgeryOpen Reduction and Internal Fixation of the nonunion site | Procedure or surgery | EBI Bone Healing System + Surgery, Placebo Device + Surgery |
Primary outcome
Percentage of Successful 5th Metatarsal Unions Achieved.
Time frame: 24 Weeks
Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing.
1 secondary outcome
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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.
John Evangelista study director
Zimmer Biomet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBI Bone Healing System and Surgery in people with Nonunion of Fracture of Fifth Metatarsal, run by Zimmer Biomet at 2 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 3 inclusion and 8 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Successful 5th Metatarsal Unions Achieved. (time frame: 24 Weeks). 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 21 Jun 2017.