PureGen: Radiographic Analysis of Fusion for ACDF (NCT01291134) | Clinical Trial Compass
TerminatedNot Applicable
PureGen: Radiographic Analysis of Fusion for ACDF
Stopped: Product is no longer on the market
United States30 participantsStarted 2011-02
Plain-language 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).
Who can participate
Age range18 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 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).