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)

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).

Study Overview

• Status: Terminated
• Conditions: Cervical Degenerative Disc Disease
• Intervention / Treatment: Biological: PureGen Osteoprogenitor Cell Allograft

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92008
      • Alphatec Spine Inc.
  • Connecticut
    • Middletown, Connecticut, United States, 06457
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
    • Raleigh, North Carolina, United States, 27607

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cervical Degenerative Disc Disease; Subjects suffering from symptoms of cervical degenerative disc disease in one to four contiguous levels between C3 and T1.	Biological: PureGen Osteoprogenitor Cell Allograft; PureGen Osteoprogenitor Cell Allograft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	Proportion of subjects with fusion at the 12-month visit	12 months

Collaborators and Investigators

• Sponsor: Alphatec Spine, Inc.
• Investigators: Study Director: Bita P. Ghadimi, Alphatec Spine, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (Estimate): February 8, 2011

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: PRO-000053