Pilot Study to Assess Safety/Prelimary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery

NCT00798239 | Unknown Phase 1 DMC

• 1 other identifier: PFX-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief Summary

This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.

Conditions

Degenerative Disc Disease; Spondylolisthesis

Keywords

DDD; Spondylolisthesis; Spine Fusion; Lumbar Spine; Bone Graft

Outcome Measures

Primary Outcomes (1)

• Removal/revision or supplemental fixation of the graft material requiring reoperation at the index level, Safety (adverse events), Fusion "success" based on X-rays, Change from baseline in neurological exam scores and ODI scores

  12 months post surgery

Secondary Outcomes (1)

• Volume of blood loss/transfused blood during surgery, Blinded independent assessment of fusion by CT and other radiographic assessments, Change from baseline in pain scores using VAS and change from baseline in SF-36 v2™ total and subscale scores

  12 months post surgery

Study Arms (3)

Control

ACTIVE COMPARATOR

The control arm is Iliac Crest Autograft

Other: Iliac crest autograft

Prefix 150

EXPERIMENTAL

Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules

Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules

Prefix 750

EXPERIMENTAL

Prefix (AMPLEX) B2A Enhanced Ceramic Granules

Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules

Interventions

Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules DEVICE

150 micorgrams/cc BVF

Also known as: AMPLEX

Prefix 150

Iliac crest autograft OTHER

autograft

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of DDD requiring single level fusion (L2-S1) with up to Grade I Spondylolisthesis
• Have a preoperative screening qualifying VAS and ODI scores
• Be a skeletally mature male or a non-pregnant, non-lactating female, age 18 -70 inclusive
• Have not been sufficiently responsive to at least 6 months of non-operative treatment prior to study enrollment

You may not qualify if:

• Are female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following the surgery
• A history of previous surgery in the lumbar spine with or without attempted fusion
• Grade II or greater spondylolisthesis
• More than 0 degrees of kyphosis at the operated disc space
• Evidence of scoliosis in the lumbar region of more than 10 degrees
• Collapsed disc space with bridging osteophytes
• A systemic or local infection at the site of surgery
• An acute fracture of the spine at the time of enrollment in the study
• An active history of systemic malignancy
• A medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study
• A known hypersensitivity to any of the components of the product or a known titanium allergy or a known allergy to polyetheretherketone (PEEK)
• A history of any autoimmune disease, such as, systemic lupus erythematosus, Addison's disease, Crohn's disease, or rheumatoid arthritis
• A history of any severe allergy or anaphylaxis, or a history of hypersensitivity to protein pharmaceuticals, or have had any previous exposure to a protein pharmaceutical
• Are receiving treatment (before or during surgery) with a drug (e.g., steroids, methotrexate, etc.) that interferes with bone metabolism or are being treated with a bone growth stimulator
• A medical condition requiring radiation, chemotherapy or immunosuppression, or a medical condition requiring systemic corticosteroids

Sponsors & Collaborators

• BioSurface Engineering Technologies, Inc: lead

Study Sites (5)

Confidential

Calgary, Alberta, T2N 2T9, Canada

Location

Confidential

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Confidential

Ottawa, Ontario, K1Y 4E9, Canada

Location

Confidential

Toronto, Ontario, M4N 3M5, Canada

Location

Confidential

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Brent Atkinson, PhD

  BioSurface Engineering Technologies, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 26, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

CA (5)