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Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)

Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF): Evaluation of Radiographic and Patient Outcomes

NCT00947583•NuVasive

Summary

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a TLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.

Detailed Description

This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive TLIF 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 TLIF 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 BMP.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
•2. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to S1)
•3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
•4. 18-70 years of age at the date of written informed consent
•5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
•6. Expected to survive at least 2 years beyond surgery
•7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
•8. Signed and dated Informed Consent Form

Exclusion Criteria

•1. Patient has a mental or physical condition that would limit the ability to comply with study requirements
•2. Lumbar spine abnormality requiring treatment at more than two levels
•3. Systemic or local infection; active or latent
•4. Previous failed fusion at the operative level
•5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
•6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
•7. Pregnant, or plans to become pregnant during the study
•8. Subject is a prisoner
•9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
•10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents
+1 more criteria

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

December 24, 2025

Enrollment

ACTUAL participants

Conditions

Degenerative Disc Disease

Interventions

Osteocel Plus

BIOLOGICAL

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

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Degenerative Disc Disease

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RECRUITINGNA

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Real World Data Collection on the Synergy Disc