Clinical trial NCT00948831: Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)
Official title: Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF): Evaluation of Radiographic and Patient Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease, Lumbar
Keywords: biologics
fusion rates
lumbar fusion
ALIF
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2009-07-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Existing clinic patients

Brief summary: This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in an ALIF 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 ALIF 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 ALIF 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 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

Primary outcomes:
measure: To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ALIF subjects.
timeFrame: from pre-op to 24-months follow-up
Secondary outcomes:
measure: To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP).
timeFrame: from pre-op to 24-month follow-up
measure: To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).
timeFrame: from pre-op to 24-months post-op
measure: To evaluate and compare each outcome with respect to surgical time and blood loss.
timeFrame: pre-op to 24-month follow-up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Indianapolis
country: United States
facility: OrthoIndy, Indiana Orthopedic Hospital
state: Indiana
city: Kokomo
country: United States
facility: Indiana Spine Group, St. Joseph's Hospital
state: Indiana
city: Edina
country: United States
facility: Twin Cities Orthopaedics, University of Minnesota Medical Center
state: Minnesota
city: Billings
country: United States
facility: Ortho Montana
state: Montana
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Austin
country: United States
facility: Central Texas Spine Institute, Northwest Hills Surgical Hospital
state: Texas
Study officials:
References: