INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT01491542
First received: December 12, 2011
Last updated: August 1, 2013
Last verified: December 2011

December 12, 2011
August 1, 2013
April 2003
November 2006   (final data collection date for primary outcome measure)
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. Postoperative Oswestry score improvement of at least 15% from preoperative;
  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".
Same as current
Complete list of historical versions of study NCT01491542 on ClinicalTrials.gov Archive Site
  • General Health Status (SF-36) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Pain Status (back pain, leg pain) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Patient Satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Patient Global Perceived Effect [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study
A Pilot Prospective Randomized Clinical Investigation of INFUSE® Bone Graft and MASTERGRAFT® Granules With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease

The purpose of this pilot clinical trial is to evaluate the feasibility of using the investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON® Spinal System) as a method of facilitating spinal fusion in patients with symptomatic degenerative disc disease.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Degenerative Disc Disease
  • Device: INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®
    The INFUSE® Bone Graft component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2(rhBMP-2) and an absorbable collagen sponge (ACS)carrier. The MASTERGRAFT® Granules will be used as a type of bulking agent to provide compression resistance.
    Other Names:
    • Infused Bone Graft
    • MasterGraft
  • Device: Autogenous Bone / CD HORIZON® Spinal System
    The control will be autogenous bone taken from the iliac crest of the patient and placed bilaterally across two adjacent transverse processes and used in conjunction with the CD HORIZON® Spinal System.
    Other Name: Autograft
  • Experimental: rhBMP-2 / ACS
    Intervention: Device: INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®
  • Active Comparator: Autogenous bone
    Intervention: Device: Autogenous Bone / CD HORIZON® Spinal System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2007
November 2006   (final data collection date for primary outcome measure)

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], functional deficit and/or neurological deficit) and radiographic studies (e.g.,C T, MRl, X-Ray,etc.) to include one or more of the following:

    • instability (defined as angulation ≥ 5° and/or translation ≥ 4mm,based on flexion/extension 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. Requires fusion of a single level disc space 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 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 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 level.
  2. Had previous spinal fusion surgical procedure at the involved level or an adjacent level.
  3. Requires spinal fusion at more than one lumbar level.
  4. Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
  5. Has a documented history of osteopenia or osteomalacia.
  6. Has any of the following that may be associated with diagnosis of osteoporosis (if "Yes" to any of the below risk factors,a dual x-ray absorptiometry (DEXA) scan will be required to determine eligibility.)

    • Postmenopausal non-black female over 60 years of age and weighs less than 140 pounds.
    • Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
    • Male over the age of 70.
    • 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,then the patient is excluded from the study.
  7. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
  8. Has overt or active bacterial infection, either local or systemic.
  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 or alcohol and/or drug abuse.
  14. ls a tobacco user at the time of surgery.
  15. 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).
  16. Has a documented history of autoimmune disease ( e.g. Systemic Lupus Erythematosus or dermatomyositis).
  17. Has a history of exposure to implanted collagen or silicone implants.
  18. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
  19. 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/MASTERGRAFT® Granules implantation.
  20. Has received any previous exposure to any/all BMP's of either human or animal extraction.
  21. Has a history of allergy to bovine products or a history of anaphylaxis.
  22. Has a history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease,renal osteodystrophy, Ehlers- Danlos syndrome,or osteogenesis imperfecta).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01491542
P01-11
Yes
Medtronic Spinal and Biologics
Medtronic Spinal and Biologics
Not Provided
Not Provided
Medtronic Spinal and Biologics
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP