Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)

Sponsor

NuVasive (Industry)

Overall Status

Completed

CT.gov ID

NCT00948831

Collaborator

(none)

Enrollment

Locations

Duration (Months)

7.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease, Lumbar	Biological: Osteocel Plus

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.

Study Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Outcome Measures

Primary Outcome Measures

To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ALIF subjects. [from pre-op to 24-months follow-up]

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). [from pre-op to 24-month follow-up]
To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain). [from pre-op to 24-months post-op]
To evaluate and compare each outcome with respect to surgical time and blood loss. [pre-op to 24-month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)
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
Subject is a prisoner
Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
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
Participating in another clinical study that would confound study data

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at San Francisco	San Francisco	California	United States	94143
2	OrthoIndy, Indiana Orthopedic Hospital	Indianapolis	Indiana	United States	46278
3	Indiana Spine Group, St. Joseph's Hospital	Kokomo	Indiana	United States	46901
4	Twin Cities Orthopaedics, University of Minnesota Medical Center	Edina	Minnesota	United States	55435
5	Ortho Montana	Billings	Montana	United States	59101
6	Cleveland Clinic	Cleveland	Ohio	United States	44195
7	Central Texas Spine Institute, Northwest Hills Surgical Hospital	Austin	Texas	United States	78731