Clinical Study of rhBMP-2/BCP With the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT01494454
First received: December 12, 2011
Last updated: August 1, 2013
Last verified: December 2011
  Purpose

This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the patients with degenerative disc disease.


Condition Intervention
Degenerative Disc Disease
Device: rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System
Device: Autograft/TSRH® or autograft/CD HORIZON® Spinal System.

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 Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With Either the TSRH® Spinal System or the CD Horizon® Spinal System for Posterolateral Lumbar Fusion in Patients With DDD

Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • Fusion [ Time Frame: 24 month ] [ Designated as safety issue: No ]

    Fusion is defined as:

    1. Evidence of bridging trabecular bone.
    2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs as determined by superimposing the two views, one upon the other; b. Less than 5° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs;
    3. Absence of radiolucent lines completely through the fusion mass.

  • 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 for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15


Secondary Outcome Measures:
  • 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. Neurological status is based on four types of measurements (sections): motor, sensory, reflexes and straight leg raise.

  • Hip (Donor Site) pain [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • General health status (SF-36) [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Pain status (back pain, leg pain) [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Patient global perceived effect [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: August 1999
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rhBMP-2/BCP Device: rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System
rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, either the TSRH® Spinal System or CD HORIZON® Spinal System.
Other Name: Recombinant human bone morphogenetic protein
Active Comparator: Autograft Device: Autograft/TSRH® or autograft/CD HORIZON® Spinal System.
Either the TSRH® Spinal System or the CD HORIZON® Spinal System with autogenous bone taken from the patient's iliac crest.
Other Name: Autogenous bone graft

  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° translation >= 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 >= 30.
  3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's classification (Meyerding HW, 1932).
  4. Has one or two adjacent levels from L1 to S1 requiring fusion.
  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, agrees to not become pregnant for 1 year following surgery.
  8. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion Criteria:

  1. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 spondylolisthesis at the involved levels.
  2. Had previous spinal fusion surgical procedure at the involved levels.
  3. Has a condition that requires postoperative medications that interfere with fusion, such as steroids.
  4. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
  5. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
  6. Has overt or active bacterial infection, either local or systemic.
  7. Is grossly obese, i.e., weight > 40% over ideal for their age and height.
  8. Has fever ( temperature > 101°F oral) at the time of surgery.
  9. Has a documented titanium alloy allergy or intolerance.
  10. Is mentally incompetent. If questionable, obtain psychiatric consult.
  11. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
  12. Is a prisoner.
  13. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
  14. Is a tobacco user at the time of surgery.
  15. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery ( e.g., NSAIDS, steroids or methotrexate).
  16. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
  17. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
  18. 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/BCP implantation.
  19. Has received any previous exposure to any/all BMP's of either human or animal extraction.
  20. Has a history of severe allergy ( anaphylaxis).
  21. 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: NCT01494454     History of Changes
Other Study ID Numbers: C-9807
Study First Received: December 12, 2011
Last Updated: August 1, 2013
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 27, 2014