Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF) (NCT00947583) | Clinical Trial Compass
CompletedNot Applicable
Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)
United States19 participantsStarted 2009-05
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
✓. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to S1)
✓. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
✓. 18-70 years of age at the date of written informed consent
✓. Able to undergo surgery based on physical exam, medical history and surgeon judgment
✓. Expected to survive at least 2 years beyond surgery
✓. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
✓. Signed and dated Informed Consent Form
Exclusion criteria
✕. Patient has a mental or physical condition that would limit the ability to comply with study requirements
✕. Lumbar spine abnormality requiring treatment at more than two levels
✕. Systemic or local infection; active or latent
✕. Previous failed fusion at the operative level
✕. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
What they're measuring
1
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for TLIF subjects.
✕. 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)
✕. Pregnant, or plans to become pregnant during the study