Lumbar FusionNCT01833962
A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion
An observational study of Lumbar Fusion, run by OrthoGeorgia at 1 site in United States.
Trial summary
The purpose of this study is to assess fusion status in patients who underwent spinal fusion with Actifuse synthetic bone graft versus other bone graft material (including autograft) in achieving lumbar spinal fusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Fusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All study patients will be extracted from our current patient population. A total of 50 patients treated with Actifuse and 50 patients treated with other synthetic bone grafting substitutes
Who may be able to join
- Any patient 18 years of age or older
- Patients with a minimum follow up of 1 year
- Patients who have previously undergone TLIF, PLIF,PLF, XLIF procedures
Who cannot join
- Patients under the age of 18
- Any patient with less than 1 year of follow up history at the time of first data analysis
- Any patient that the primary investigator deems as an unfit candidate
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess fusion status in patients who underwent spinal fusion with Actifuse synthetic bone graft versus other bone graft material (including autograft) in achieving lumbar spinal fusion.
- Conditions
- Lumbar Fusion
- Keywords
- Lumbar fusion rates, Actifuse synthetic bone graft, Baxter Healthcare, Other synthetic bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Actifuse | Patients who recieved Actifuse synthetic bone brafting material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of fusion prior to or at 12 months postoperatively
Measured: 6 - 12 months year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar FusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoGeorgia
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- William B Dasher, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833962
- Sponsor's protocol ID
- 001-3708
- Status last verified
- Apr 2015
- First submitted
- 12 Apr 2013
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion
- ClinicalTrials.gov ID
- NCT01833962
- Acronym / sponsor ID
- 001-3708
- Conditions
- Lumbar Fusion
- Keywords
- Lumbar fusion rates, Actifuse synthetic bone graft, Baxter Healthcare, Other synthetic bone graft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- OrthoGeorgiaUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Apr 2013 (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 study is to assess fusion status in patients who underwent spinal fusion with Actifuse synthetic bone graft versus other bone graft material (including autograft) in achieving lumbar spinal fusion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actifuse | – | –Patients who recieved Actifuse synthetic bone brafting material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All study patients will be extracted from our current patient population. A total of 50 patients treated with Actifuse and 50 patients treated with other synthetic bone grafting substitutes
Key inclusion criteria (3 listed)
- Any patient 18 years of age or older
- Patients with a minimum follow up of 1 year
- Patients who have previously undergone TLIF, PLIF,PLF, XLIF procedures
Key exclusion criteria (3 listed)
- Patients under the age of 18
- Any patient with less than 1 year of follow up history at the time of first data analysis
- Any patient that the primary investigator deems as an unfit candidate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Achievement of fusion prior to or at 12 months postoperatively
Time frame: 6 - 12 months year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Related InfoLink provided by the sponsor.
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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.
William B Dasher, MD principal investigator
Physician
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 Lumbar Fusion, run by OrthoGeorgia 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 3 inclusion and 3 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 Apr 2015. 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?
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?
Achievement of fusion prior to or at 12 months postoperatively (time frame: 6 - 12 months year). 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 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.