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NCT00254852 · ClinicalTrials.gov registry record · NA
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
A NA study, sponsored by Exactech.
- Terminated
- Registry status
- NA
- Development phase
- 94
- Enrollment target
NCT00254852 is a NA study that was terminated before completion, run by Exactech. The registered enrollment target is 94 participants.
The verdict
NCT00254852, a NA study, was terminated before completion, sponsored by Exactech.
- TERMINATED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
Study Summary
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae), L2 and below. The primary endpoint will be the assessment of fusion by evaluation of x-rays taken following surgery at each visit. The x-ray evaluation will be conducted by a radiologist who is blinded to the type of treatment each patient has received. Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative (post-op). Questionnaires and x-rays will be completed at each visit and a computed tomography (CT) scan will be taken at the 12 month visit(and used to aid in assessment of bridging bone, where appropriate).
Interventions
- PROCEDURE Anterior Lumbar Interbody Fusion (ALIF)
- PROCEDURE Posterior Lateral Fusion (PLF)
- PROCEDURE Transforaminal lumbar interbody fusion (TLIF)
- PROCEDURE Posterior lumbar interbody fusion (PLIF)
- PROCEDURE Extreme lateral interbody fusion (XLIF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2005-10 |
| Est. Completion | 2011-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00254852
The ClinicalTrials.gov registry entry for NCT00254852 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exactech, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Anterior Lumbar Interbody Fusion (ALIF) is the first listed.
NCT00254852 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00254852 about?
NCT00254852 is a clinical study titled "Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft". The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae), L2 and below. The primary endpoint will be the assessment of fusion by ...
What is the current status of trial NCT00254852?
This trial is currently terminated. It is a NA study. The enrollment target is 94 participants. The study started on 2005-10. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00254852?
The interventions under investigation include: Anterior Lumbar Interbody Fusion (ALIF) (PROCEDURE), Posterior Lateral Fusion (PLF) (PROCEDURE), Transforaminal lumbar interbody fusion (TLIF) (PROCEDURE), Posterior lumbar interbody fusion (PLIF) (PROCEDURE), Extreme lateral interbody fusion (XLIF) (PROCEDURE).
Who is sponsoring clinical trial NCT00254852?
This trial is sponsored by Exactech, which has 12 total clinical trials registered on ClinicalTrials.gov.
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