Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion

NCT01018771 | Completed DMC

• 2 other identifiers: CIP0803PLFACTRN12609000548235
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomised study. Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion. Secondary objectives: Assess clinical outcome measurements.

Conditions

Degenerative Disc Disease

Keywords

actifuse; INFUSE; InductOs; DDD; Degenerative disc disease; PLF; posterolateral lumbar fusion; bone substitute; bone graft; synthetic bone substitute; spinal surgery

Outcome Measures

Primary Outcomes (1)

• Fusion, defined as evidence of bridging trabecular bone present at 1 year

  1 year

Secondary Outcomes (1)

• Improvement in the following clinical outcomes measurements: Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire; Quality of Life as measured by Short Form Health Survey (SF36)and Neurological Status

  1 year

Study Arms (2)

Actifuse ABX

EXPERIMENTAL

Actifuse ABX bone substitute

Procedure: Actifuse ABX

INFUSE, plus Mastergraft granules

ACTIVE COMPARATOR

Procedure: INFUSE, plus Mastergraft granules

Interventions

Actifuse ABX PROCEDURE

bone graft to be used in posterolateral instrumented lumbar fusion

Actifuse ABX

INFUSE, plus Mastergraft granules PROCEDURE

bone graft to be used in posterolateral instrumented lumbar fusion

INFUSE, plus Mastergraft granules

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have degenerative disc disease of the lumbar spine as indicated by back pain of discogenic/degenerative origin with or without leg pain and has one or more of the following conditions as documented by Plain X-Rays, CT Scan or MRI Scan:
• Modic changes.
• High intensity changes in the annulus.
• Loss of disc height.
• Decreased hydration of the disc.
• Canal stenosis with or without Spondylotic slip.
• Gross facet joint changes requiring fusion for treatment.
• Have documented annular pathology by other means. (e.g. with discography).
• Have a preoperative Oswestry Back Disability Score of 30 or more.
• Aged 18 to 75 years and skeletally mature at time of surgery.
• Have not responded to non-operative treatment (e.g. bed rest, physical therapy, medications and/or spinal injections) for a period of six months.
• If of childbearing potential, patient is non-pregnant, non-nursing and agrees not to become pregnant for one year following surgery.
• Is will to and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

You may not qualify if:

• Has had previous failed attempts at fusion surgery at the involved level(s).
• Has a diagnosis of spinal infection tumour or trauma.
• Requires surgery at more than two (2) levels.
• Has osteoporosis (excluding osteopenia) as evidenced on plain X-rays, CT Scans (or DEXA scan in cases of doubt).
• Is pregnant.
• Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
• Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g. steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs.
• Has a history of autoimmune disease.
• Has a history of exposure to injectable collagen implants.
• Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
• Has received treatment with an investigational therapy (device and/or pharmaceutical) within 30 days prior to surgery or such treatment is planned during the 24 months following surgery.
• Has received any previous exposure to any/all BMPs of either human or animal extraction.
• Has a history of allergy to bovine products or a history of anaphylaxis.
• Has a history of any endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal oseodystrophy, Ehlos-Danlos syndrome or Osteogenesis Imperfecta).
• Has any disease that would preclude accurate clinical evaluation (e.g. neuromuscular disease etc).

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Apatech, Inc.: collaborator

Study Sites (1)

Moloney & Associates

Wollongong, NSW2522, Australia

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Huub Kruewel, Ph.D

  Director, Medical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

AU (1)