Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT00947583
First received: July 24, 2009
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Degenerative Disc Disease
Biological: Osteocel Plus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF): Evaluation of Radiographic and Patient Outcomes

Further study details as provided by NuVasive:

Primary Outcome Measures:
  • To evaluate the fusion rates of Osteocel Plus in one or two level(s) for TLIF subjects. [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP). [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: Yes ]
  • To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain). [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: Yes ]
  • To evaluate and compare each outcome with respect to surgical time and blood loss. [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: May 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Osteocel Plus
    biologic
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Existing clinic patients

Criteria

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
  11. Participating in another clinical study that would confound study data
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947583

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
NuVasive
  More Information

Additional Information:
No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT00947583     History of Changes
Other Study ID Numbers: NUVA.OC-0804
Study First Received: July 24, 2009
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NuVasive:
fusion rates
TLIF
Osteocel Plus
biologics
lumbar fusion

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014