Clinical trial NCT01291134: PureGen: Radiographic Analysis of Fusion for ACDF
Official title: PureGen Osteoprogenitor Cell Allograft: A Radiographic Analysis of Rate and Quality of Fusion in Patients Undergoing Anterior Cervical Discectomy and Fusion (ACDF)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cervical Degenerative Disc Disease
Lead sponsor: Alphatec Spine, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects suffering from symptoms of cervical degenerative disc disease (DDD) in one to four contiguous levels between C3 and T1.

Brief summary: The purpose of this study is to evaluate the rate and quality of spinal fusion utilizing PureGen Osteoprogenitor Cell Allograft in Anterior Cervical Discectomy and Fusion (ACDF).

Detailed description: This is a prospective, multi-center, post-market, observational study assessing subjects undergoing cervical interbody fusion surgery to treat cervical degenerative disc disease (DDD)

Patients diagnosed with cervical degenerative disc disease will be screened for enrollment based on inclusion and exclusion criteria outlined in this protocol. Subjects who are successfully screened and sign an informed consent will undergo ACDF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), a radiolucent cervical interbody spacer, and Trestle or Reveal Anterior Cervical Plating System (plate and screw fixation system).

Subjects will be followed at 6- weeks, 3-, 6-, and 12-month post-operative visits. Standard radiographs will be taken at these visits to assess fusion rate and quality. SF-12, NDI and VAS self assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography scan will be taken at the 6 month post operative exam to further assess rate and quality of fusion. A conditional 12-month post operative CT may also be taken. Procedure related and device related adverse events will be monitored throughout the study.

Outcome data will be compared to published and/or retrospective data for the standard of care for DDD patients undergoing ACDF.

Eligibility criteria: Inclusion Criteria:

* Persistent neck and/or arm pain consistent to symptomatic cervical degenerative disc disease
* Moderate Neck Disability Index
* Unresponsive to conservative treatment for at least 6 weeks

Exclusion Criteria:

* More than 4 levels requiring surgical treatment
* Prior failed fusion surgery at the index level(s)
* Systemic or local infection in the disc or cervical spine, past or present
* Active systemic disease
* Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
* Known or suspected history of alcohol and/or drug abuse
* Involved in pending litigation or worker's compensation relating to the spine
* Pregnant or plans to become pregnant during the duration of the study
* Insulin-dependent diabetes mellitus
* Life expectancy less than study duration
* Any significant psychological disturbance that in the opinion of the Investigator could impair consent process or ability to complete self-assessment questionnaires
* BMI greater than 40
* Undergoing chemotherapy or radiation treatment, or chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs
* Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).

Primary outcomes:
measure: Fusion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Alphatec Spine Inc.
state: California
city: Middletown
country: United States
state: Connecticut
city: Greensboro
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
Study officials:
affiliation: Alphatec Spine, Inc.
name: Bita P. Ghadimi
role: STUDY_DIRECTOR
References: