Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
Public ClinicalTrials.gov record NCT00948532. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®): Evaluation of Radiographic and Patient Outcomes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their XLIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).
Study identification
- NCT ID
- NCT00948532
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 104 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2009 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Oct 2012 (Actual)
- Last update posted
- Dec 24, 2025
2009 – 2012
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Shiley Center for Orthopaedic, Scripps Green Hospital | La Jolla | California | 92037 | — |
| Broward Spine Institute | Hollywood | Florida | 33021 | — |
| South Florida Spine Institute, Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Southeastern Spine Center, Doctors Hospital of Sarasota | Sarasota | Florida | 34232 | — |
| USF, Tampa General Hospital | Tampa | Florida | 33606 | — |
| Pinnacle Orthopaedics, Wellstone Kennestone Hospital | Marietta | Georgia | 30060 | — |
| The Spine Center of DuPage Medical Group, Edward Hospital | Naperville | Illinois | 60540 | — |
| Indiana Center for Neurosurgery | Indianapolis | Indiana | 46219 | — |
| Columbia Orthopaedic Group, Boone Hospital Center | Columbia | Missouri | 65205 | — |
| Spine Midwest, St. Mary's Health Center | Jefferson City | Missouri | 65101 | — |
| Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada | Las Vegas | Nevada | 89109 | — |
| Buffalo Spine Surgery, Kenmore Mercy | Lockport | New York | 14094 | — |
| Duke University Medical Center | Chapel Hill | North Carolina | 27710 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00948532, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 24, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00948532 live on ClinicalTrials.gov.