Tibia Fracture Non Union BoneNCT00726193
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
An observational study of Tibia Fracture Non Union Bone, run by Zimmer Biomet at 1 site in United States.
Trial summary
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tibia Fracture Non Union Bone
- What is being tested?
- OsteoGen
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Apr 2008
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: private practice patients
Who may be able to join
- Diagnosis of a tibia nonunion.
- Male or female between ages of 18 and 75 years old, inclusive
Who cannot join
- Subject has open wounds or underlying osteomyelitis.
- Subject has associated multiple traumas, and/or fractures that are not anatomically reduced or lose reduction at later time points.
- 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.
- Subject has active cancer.
- Subject has severe peripheral vascular disease (ABI <0.4)
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Foot and Ankle Center
Columbus, Ohio, 43231
About this study
Official title: A Prospective Randomized Multi - Center Clinical Outcomes Collection Study To Analyze The Effect Of Ebi Osteogen™ Direct Current Stimulator On The Surgical Reconstruction Of Tibia Nonunions
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.
Read the detailed description
This clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.
- Conditions
- Tibia Fracture Non Union Bone
- Being tested
- OsteoGen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteoGenDevice
OsteoGen Implatable stimulator
| Study group | Role | What they receive |
|---|---|---|
| 1 - standard films | Tibia reconstruction surgery with OsteoGen™ with standard radiographs Receives: Device: OsteoGen | |
| 2 - Standard films plus CT | Tibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks. Receives: Device: OsteoGen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure for this trial will be the percentage of successful tibia unions achieved
Measured: 8 Months
Secondary outcomes (1)
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline)
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJun 2006
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Slow enrollment, lack of follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibia Fracture Non Union BoneStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Batts, Study director, Biomet Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726193
- Sponsor's protocol ID
- CS-012
- Status last verified
- Jan 2019
- First submitted
- 29 Jul 2008
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multi - Center Clinical Outcomes Collection Study To Analyze The Effect Of Ebi Osteogen™ Direct Current Stimulator On The Surgical Reconstruction Of Tibia Nonunions
- ClinicalTrials.gov ID
- NCT00726193
- Acronym / sponsor ID
- CS-012
- Conditions
- Tibia Fracture Non Union Bone
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment, lack of follow up
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Jul 2008 (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 purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.
Detailed description
This clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - standard films | – | Device: OsteoGenTibia reconstruction surgery with OsteoGen™ with standard radiographs |
| 2 - Standard films plus CT | – | Device: OsteoGenTibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- private practice patients
Key inclusion criteria (2 listed)
- Diagnosis of a tibia nonunion.
- Male or female between ages of 18 and 75 years old, inclusive
Key exclusion criteria (6 listed)
- Subject has open wounds or underlying osteomyelitis.
- Subject has associated multiple traumas, and/or fractures that are not anatomically reduced or lose reduction at later time points.
- 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.
- Subject has active cancer.
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 |
|---|---|---|
| OsteoGenOsteoGen Implatable stimulator | Device | 1 - standard films, 2 - Standard films plus CT |
Primary outcome
The primary outcome measure for this trial will be the percentage of successful tibia unions achieved
Time frame: 8 Months
1 secondary outcome
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline)
Time frame: 8 Months
Results and safety
The study was stopped early (reason given: Slow enrollment, lack of follow up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: Undecided
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A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
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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.
Joel Batts study director
Biomet Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibia Fracture Non Union Bone, run by Zimmer Biomet at 1 site 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 2 inclusion and 6 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 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 (reason given: Slow enrollment, lack of follow up). 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?
The primary outcome measure for this trial will be the percentage of successful tibia unions achieved (time frame: 8 Months). 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 24 Jan 2019.