A Pilot Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT01494428
First received: December 12, 2011
Last updated: August 1, 2013
Last verified: December 2011
  Purpose

The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.


Condition Intervention
Degenerative Disc Disease
Device: rhBMP-2/ACS/allograft bone dowel
Device: Autogenous bone/allograft bone dowel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • Severity and Rate of Implant-Associated Adverse Events [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • Rate of Implant Revision, Removal and Supplemental Fixation Procedures [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • Incidence of Permanent Adverse Events [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • Fusion [ Time Frame: 24 month ] [ Designated as safety issue: No ]

    Fusion is defined as:

    1. Bone observed connecting with the vertebral bodies above and below either through the implants; lateral to or between the implants; or anterior/posterior to the implants.
    2. Angulation < 5°.
    3. Translation < 3mm.
    4. Absence of radiolucent lines around more than 50% of either implant.

  • Disc Height Measurement [ Time Frame: 24 month ] [ Designated as safety issue: No ]
    Disc height will be measured postoperative and compared to the preoperative measurement. Maintenance or improvement in disc height will be determined a success.

  • Pain/Disability Status [ Time Frame: 24 month ] [ Designated as safety issue: No ]
    The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15

  • Neurological Status [ Time Frame: 24 month ] [ Designated as safety issue: No ]
    Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.


Secondary Outcome Measures:
  • Nature and Frequency of Adverse Events Not Associated with the Implants [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • Rate of Reoperation Procedures [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • Hip (Donor Site) Pain Status [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Patient Satisfaction/Quality of Life Status (SF-36) [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Pain Status (Numerical Rating Scale) [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Overall Success [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

    A patient will be considered an overall success if all of the following conditions are met:

    1. fusion
    2. disc height maintenance or improvement
    3. pain/disability (Oswestry) improvement
    4. maintenance or improvement in neurological status
    5. no permanent adverse event
    6. no additional surgical procedure classified as a "failure."


Enrollment: 46
Study Start Date: April 1998
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rhBMP-2/ACS Device: rhBMP-2/ACS/allograft bone dowel
The rhBMP-2/ACS will be used in conjunction with an allograft bone dowel.
Other Name: Recombinant human bone morphogenetic protein-2
Active Comparator: Autogenous Bone Device: Autogenous bone/allograft bone dowel
An allograft bone dowel contains autogenous bone taken from the patient's iliac crest.
Other Name: Autograft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g.,pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit)and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:

    • instability( defined as angular motion > 5° and/or translation >= 2-4mm, based on Flex/Ext radiographs);
    • osteophyte formation;
    • decreased disc height;
    • thickening of ligamentous tissue;
    • disc degeneration or herniation; and/or
    • facet joint degeneration.
  2. Has preoperative Oswestry score > 35.
  3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
  4. Has single-level symptomatic degenerative involvement from L4 to S1.
  5. Is at least 18 years of age, inclusive, at the time of surgery.
  6. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
  7. If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
  8. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion Criteria:

  1. Had previous anterior spinal fusion surgical procedure at the involved level.
  2. Has a condition which requires postoperative medications that interfere with fusion, such as steroids or nonsteroidal antiinflammatory drugs (this does not include low dose aspirin for prophylactic anticoagulation).
  3. Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
  4. Has presence of active malignancy.
  5. Has overt or active bacterial infection, either local or systemic.
  6. Is obese, i.e., weight greater than 40% over ideal for their age and height.
  7. Has fever (temperature> 101° F oral) at the time of surgery.
  8. Is mentally incompetent. If questionable, obtain psychiatric consult.
  9. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
  10. Is a prisoner.
  11. Is an alcohol and/or drug abuser.
  12. Is a tobacco user at the time of surgery.
  13. Patient has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).
  14. Patient has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
  15. Patient has a history of exposure to injectable collagen implants.
  16. Patient's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
  17. Patient has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
  18. Patient has received any previous exposure to BMP.
  19. Patient has a history of severe allergy, an allergy to bovine products, or a history of anaphylaxis.
  20. Patient has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT01494428     History of Changes
Other Study ID Numbers: C-9703
Study First Received: December 12, 2011
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Spinal and Biologics:
symptomatic degenerative disc disease

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 30, 2014