PureGen: Radiographic Analysis of Fusion for ACDF

Stopped early

Conditions studied: Cervical Degenerative Disc Disease

In brief

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).

Key facts

Study ID

NCT01291134

Run by

Alphatec Spine, Inc.

People needed

30

Starts

2011-02-01

Expected to finish

2013-08-01

Last updated by the study team

2022-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Alphatec Spine Inc. — Carlsbad, California, United States
• Study site — Middletown, Connecticut, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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