Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion

NCT01013389 | Completed DMC

• 3 other identifiers: CIP0702PLFACTRN12609000527268EudraCT Number: 2009-012672-27
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion. The secondary objective of this clinical trial is to assess clinical outcome measurements.

Conditions

Degenerative Disc Disease

Keywords

actifuse; INFUSE; InductOs; DDD; degenerative disk disease; PLIF; PITF; PLF; poterolateral lumber fusion; Bone substitute; bone graft; synthetic bone substitute

Outcome Measures

Primary Outcomes (1)

• Fusion, defined as evidence of bridging trabecular bone present at 1 year as assessed by CT scan as well as a determination of no motion as assessed by plain radiographs.

  1 year

Secondary Outcomes (1)

• Improvement clinical outcomes measurements compared to pre-opscores: 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 master granules (MGG)

ACTIVE COMPARATOR

synthetic bone substitute used in posterolateral instrumented lumber fusion with interbody fusion

Procedure: INFUSE, plus master granules (MGG)

Interventions

Actifuse ABX PROCEDURE

bone substitute used for posterolateral instrumented lumbar fusion with interbody fusion

Actifuse ABX

INFUSE, plus master granules (MGG) PROCEDURE

bone substitute in posterolateral instrumented lumbar fusion with interbody fusion

INFUSE, plus master granules (MGG)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has 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).
• Has a preoperative Oswestry Back Disability Score of 30 or more.
• Aged 18 to 75 years and skeletally mature at time of surgery.
• Has 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 willing 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 general 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 (2)

Moloney & Associates

Wollongong, NSW 2500, Australia

Location

Isala Klinik

Zwolle, 8011 JW, Netherlands

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Huub Kreuwel, 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 10, 2009
• First Posted: November 13, 2009
• Study Start: June 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

NL (1); AU (1)