INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT01491477
First received: December 12, 2011
Last updated: August 1, 2013
Last verified: December 2011
  Purpose

The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal fusion in patients with cervical symptomatic degenerative disc disease.


Condition Intervention
Degenerative Cervical Disc Disease
Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™
Device: Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the Cornerstone-SR™ Allograft Ring and the ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • Overall Success [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

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

    1. fusion;
    2. pain/disability (Neck Disability Index) 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:
  • Disc Height Measurement [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • General Health Status (SF-36) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Pain Status (neck pain, arm pain) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Patient Global Perceived Effect [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: April 2002
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INFUSE™ Bone Graft Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™
Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system.
Other Name: Recombinant human bone morphogenetic protein-2
Active Comparator: Autogenous bone Device: Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™
Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.
Other Name: Autograft

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:

    • herniated disc;
    • osteophyte formation;
    • decreased disc height;
    • thickening of ligamentous tissue;
    • disc degeneration; and/or
    • facet joint degeneration.
  2. Has preoperative Neck Disability Index score > 30;
  3. Has single cervical disc disease level requiring fusion from C2 to C7;
  4. No previous surgical intervention at the involved fusion level;
  5. Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root or spinal cord compression in face of continued nonoperative management;
  6. Is at least 18 years of age, inclusive at time of surgery;
  7. If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery;
  8. Is willing and able to comply with study plan and sign the consent form.

Exclusion Criteria:

  1. Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level.
  2. Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged non-steroidal anti-inflammatory drugs excluding routine perioperative anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
  3. Has been previously diagnosed with osteopenia, or osteomalacia.
  4. Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility).

    1. Postmenopausal Non-Black female over 60 years of age and weighs less than 140 pounds.
    2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
    3. Male over the age of 70.
    4. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.

    If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture, the patient is excluded from the study.

  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. Has a documented titanium alloy allergy or intolerance.
  8. Is mentally incompetent. If questionable, obtain psychiatric consult.
  9. Is a prisoner.
  10. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
  11. 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), excluding routine perioperative anti-inflammatory drugs.
  12. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
  13. Has a history of exposure to injectable collagen implants.
  14. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
  15. 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.
  16. Has received any previous exposure to any/all BMP's of either human or animal extraction.
  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: NCT01491477     History of Changes
Other Study ID Numbers: P01-04
Study First Received: December 12, 2011
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 20, 2014