Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)

NCT01294007 | Terminated Results

• 1 other identifier: PRO-000061
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.

Conditions

Lumbar Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Fusion

  Number of patients with fusion at the 6- and conditional 12- and 24-month visit

  6, 12 and 24 month

Study Arms (2)

Study Graft Composite

EXPERIMENTAL

AlphaGraft ProFuse Demineralized Bone Scaffold are soaked in PureGen according to Preparation for Use and handling technique. The graft composite is placed on the randomized study side contralateral to the autograft bone graft per surgeon's standard technique for PLF. The wound is closed according to surgeon's standard technique. Post operative care will be according to the site specific standard of care. An avoidance of heavy physical activity and limitations on working, lifting, bending etc. are common precautions post procedure. The decision to use a post operative orthosis is left to the discretion of the Investigator.

Biological: PureGen Osteoprogenitor Cell Allograft

Control Graft Composite

ACTIVE COMPARATOR

Contralateral to the study graft composite, placement of posterolateral fusion graft composite containing iliac crest bone (5 cc/level/side) and local autograft composite (equal volume split with study side). Supplemental posterior pedicle screw fixation utilizing Zodiac, Illico or Xenon Spinal Fixation system. * A defined volume of iliac crest bone graft (indicated in table 2) is harvested and combined with 50% of the previously harvest morselized local bone * The graft composite is placed on the randomized control side using standard technique for PLF

Procedure: Autograft bone

Interventions

PureGen Osteoprogenitor Cell Allograft BIOLOGICAL

PureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation.

Study Graft Composite

Autograft bone PROCEDURE

Iliac Crest and Local Autograft Bone

Control Graft Composite

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic lumbar degenerative disc disease in up to two contiguous levels between L1 and S1
• Subjects with back and/or leg pain indicated for posterior stabilization with or without decompression at any level and posterolateral fusion (PLF)
• Unresponsive to conservative treatment for at least 6 months
• Radiographic evidence of primary diagnosis

You may not qualify if:

• More than 2 levels requiring posterolateral fusion
• Spondylolisthesis greater than Grade I
• Prior failed fusion surgery at any lumbar 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
• Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
• BMI greater than 40
• Use of post operative Spinal Cord Stimulator (SCS)
• Known or suspected history of alcohol and/or drug abuse
• Involved in pending litigation or worker's compensation related to the spine
• Pregnant or planning to become pregnant during the course of the study
• Insulin-dependent diabetes mellitus
• Life expectancy less than duration of study
• Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires

Sponsors & Collaborators

• Alphatec Spine, Inc.: lead

Study Sites (1)

Unknown Facility

Beverly Hills, California, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Saba Pasha, Director Clinical Research & Data Science
• Organization: ATEC Spine

spasha@atecspine.com

760-356-6639

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 2, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-09

Locations

US (1)