Clinical trial NCT00942045: Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)
Official title: Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease in Cervical Spine
Keywords: cervical spine
ACDF
biologics
fusion rates
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2009-07-20
Enrollment: 182
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 is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any other biologic product, during their ACDF operation. The ACDF procedure will be conducted with a radiolucent graft containment device such that progression of fusion can be adequately assessed via radiograph. 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 Bone Morphogenetic Protein (BMP).

Detailed description: A total of 175 subjects will be selected for enrollment in this study from multiple centers. The subjects will have degenerative conditions in the cervical spine and will be undergoing ACDF surgery as treatment at one or two levels. The following eligibility criteria are designed to select subjects for whom protocol treatment is considered appropriate. All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.

Eligibility criteria: Inclusion Criteria:

1. Persistent neck and/or arm pain unresponsive to conservative treatment for at least 6 weeks, unless clinically indicated sooner
2. Indicated for anterior fusion at one or two contiguous cervical levels (C3 to T1)
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. Cervical 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 that decrease the probability of survival to the two-year endpoint of the study
11. Participating in another clinical study at any time during the study participation that would confound study data

Primary outcomes:
measure: To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects.
timeFrame: from pre-op to 24-month 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-month post-op
measure: To evaluate and compare each outcome with respect to surgical time and blood loss.
timeFrame: from pre-op to 24-month follow-up
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Shiley Center for Orthopaedic, Scripps Green Hospital
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: UCSD Department of Orthpaedic Surgery, UCSD Medical Center
state: California
city: Santa Monica
country: United States
facility: The Spine Institute, St. John's Health Center
state: California
city: Tampa
country: United States
facility: University of South Florida Department of Neurosurgery, Tampa General Hospital
state: Florida
city: Marietta
country: United States
facility: Pinnacle Orthopaedics, Wellstone Kennestone Hospital
state: Georgia
city: Joliet
country: United States
facility: Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center
state: Illinois
city: Indianopolis
country: United States
facility: Indiana Center for NeuroSurgery, Indiana Surgery Center East
state: Indiana
city: Columbia
country: United States
facility: Columbia Orthopaedic Group, Boone Hospital Center
state: Missouri
city: Billings
country: United States
facility: NWREI (for Ortho Montana)
state: Montana
city: Lockport
country: United States
facility: Buffalo Spine Surgery, Kenmore Mercy
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Chillicothe
country: United States
facility: The Center for Advanced Orthopaedics, Adena Bone and Joint Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Southlake
country: United States
facility: Spine Team Texas, Texas Health Harris Methodist Hospital Southlake
state: Texas
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: NuVasive
name: Kelli Howell, MS
role: STUDY_DIRECTOR
References: