rhBMP-2/CRM/CD HORIZON® Spinal System Pilot Study (2-Level)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01491568
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Brief Summary:
The purpose of this study is to evaluate the feasibility of using the investigational implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral lumbar spinal fusion at two adjacent treatment levels in patients with symptomatic degenerative disc disease.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: rhBMP-2/CRM/CD HORIZON® Spinal System Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Compression Resistant Matrix With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic DDD at Two Adjacent Vertebral Levels
Study Start Date : July 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Investigational Device: rhBMP-2/CRM/CD HORIZON® Spinal System
rhBMP-2/CRM with the CD HORIZON® SpinalSystem
Other Name: Recombinant human bone morphogenetic protein-2

Primary Outcome Measures :
  1. Overall Success [ Time Frame: 24 month ]

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

    1. fusion;
    2. pain/disability (Oswestry) improvement;
    3. maintenance or improvement in neurological status;
    4. no serious adverse event classified as "implant associated", or "implant/surgical procedure associated";
    5. no additional surgical procedure classified as a "failure".

Secondary Outcome Measures :
  1. General health status (SF-36) [ Time Frame: 24 month ]
  2. Pain status (back pain, leg pain) [ Time Frame: 24 month ]
  3. Patient satisfaction [ Time Frame: 24 month ]
  4. Patient global perceived effect [ Time Frame: 24 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Has degenerative disc disease at two adjacent lumbar levels as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history and radiographic studies to include one or more of the following:

    • instability;
    • 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) at either treatment level.
  4. Requires fusion at two adjacent lumbar levels from L1 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 6 months.
  7. If a female of child-bearing potential, patient is non-pregnant and non-nursing and 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 or less spondylolisthesis at the involved levels.
  2. Has had previous spinal fusion surgical procedure(s) at the involved levels.
  3. Requires spinal fusion at more than two lumbar levels.
  4. Has a condition that requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs, excluding routine perioperative nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
  5. Has been previously diagnosed with osteopenia, osteomalacia, or osteoporosis, or has any of the following that may be associated with a diagnosis of osteoporosis. (If "Yes" to any of the criteria below, a dual x-ray absorptiometry [DEXA] scan will be required to determine eligibility.)

    • Previously diagnosed with osteopenia, osteomalacia, or osteoporosis.
    • Postmenopausal non-black female over 60 years of age who weighs less than 140 pounds.
    • Postmenopausal female who has sustained a nontraumatic hip, spine, or wrist fracture.
    • Male over the age of 70.
    • Male over the age of 60 who has sustained a nontraumatic hip or spine fracture. If the level of bone mineral density (BMD) is a T score of -3.5 or lower( i.e., -3.6, - 3.7, etc.) or a T score of -2.5 or lower( i.e., -2.6,
    • 2.7, etc.) with vertebral crush fracture, then the patient is excluded from the study.
  6. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
  7. Has overt or active bacterial infection, either local or systemic.
  8. Has a documented titanium alloy allergy or intolerance.
  9. Is mentally incompetent. If questionable, obtain psychiatric consult.
  10. Has a Waddell Signs of Inorganic Behavior Score of 3 or greater.
  11. Is a prisoner.
  12. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
  13. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery( e.g., steroids or methotrexate).
  14. Has a history of autoimmune disease.
  15. Has a history of exposure to injectable collagen or silicone implants.
  16. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
  17. 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/CRM implantation.
  18. Has received any previous exposure to any/all BMPs of either human or animal extraction.
  19. Has a history of allergy to bovine products or a history of anaphylaxis.
  20. Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Dalons syndrome, or osteogenesis imperfecta).

Responsible Party: Medtronic Spinal and Biologics Identifier: NCT01491568     History of Changes
Other Study ID Numbers: P04-07
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: December 2011

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

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