Study Stopped
Product is no longer on the market
PureGen: Radiographic Analysis of Fusion for ACDF
PureGen Osteoprogenitor Cell Allograft: A Radiographic Analysis of Rate and Quality of Fusion in Patients Undergoing Anterior Cervical Discectomy and Fusion (ACDF)
1 other identifier
observational
30
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2011
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 4, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMarch 3, 2022
February 1, 2022
1 year
February 4, 2011
February 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Fusion
Proportion of subjects with fusion at the 12-month visit
12 months
Study Arms (1)
Cervical Degenerative Disc Disease
Subjects suffering from symptoms of cervical degenerative disc disease in one to four contiguous levels between C3 and T1.
Interventions
PureGen Osteoprogenitor Cell Allograft.
Eligibility Criteria
Subjects suffering from symptoms of cervical degenerative disc disease (DDD) in one to four contiguous levels between C3 and T1.
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Alphatec Spine Inc.
Carlsbad, California, 92008, United States
Unknown Facility
Middletown, Connecticut, 06457, United States
Unknown Facility
Greensboro, North Carolina, 27401, United States
Unknown Facility
Raleigh, North Carolina, 27607, United States
Study Officials
- STUDY DIRECTOR
Bita P. Ghadimi
Alphatec Spine, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2011
First Posted
February 8, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
August 1, 2013
Last Updated
March 3, 2022
Record last verified: 2022-02