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Osteocel® Plus in Posterior Lumbar Interbody Fusion (PLIF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT00941980
First received: July 16, 2009
Last updated: January 7, 2014
Last verified: January 2014

July 16, 2009
January 7, 2014
June 2009
October 2012   (final data collection date for primary outcome measure)
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for PLIF subjects. [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00941980 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Osteocel® Plus in Posterior Lumbar Interbody Fusion (PLIF)
Osteocel® Plus in Posterior Lumbar Interbody Fusion (PLIF): Evaluation of Radiographic and Patient Outcomes

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a PLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells attached to 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 20,000 cases worldwide.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Existing clinic patients

Degenerative Disc Disease
Biological: Osteocel Plus
biologic
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00941980
NUVA.OC-0809
No
NuVasive
NuVasive
Not Provided
Not Provided
NuVasive
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP