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

Primary Purpose

Degenerative Disc Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®
Autogenous Bone / CD HORIZON® Spinal System
Sponsored by
Medtronic Spinal and Biologics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Symptomatic Degenerative Disc Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    rhBMP-2 / ACS

    Autogenous bone

    Arm Description

    Outcomes

    Primary Outcome Measures

    Overall Success
    A patient will be considered an overall success if all of the following conditions are met: Fusion; Postoperative Oswestry score improvement of at least 15% from preoperative; Maintenance or improvement in neurological status; No serious adverse event classified as implant associated or implant surgical procedure associated; No additional surgical procedure classified as a "failure".

    Secondary Outcome Measures

    General Health Status (SF-36)
    Pain Status (back pain, leg pain)
    Patient Satisfaction
    Patient Global Perceived Effect

    Full Information

    First Posted
    December 12, 2011
    Last Updated
    May 16, 2023
    Sponsor
    Medtronic Spinal and Biologics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01491542
    Brief Title
    INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medtronic Spinal and Biologics

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Disc Disease
    Keywords
    Symptomatic Degenerative Disc Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    rhBMP-2 / ACS
    Arm Type
    Experimental
    Arm Title
    Autogenous bone
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®
    Other Intervention Name(s)
    Infused Bone Graft, MasterGraft
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Autogenous Bone / CD HORIZON® Spinal System
    Other Intervention Name(s)
    Autograft
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Overall Success
    Description
    A patient will be considered an overall success if all of the following conditions are met: Fusion; Postoperative Oswestry score improvement of at least 15% from preoperative; Maintenance or improvement in neurological status; No serious adverse event classified as implant associated or implant surgical procedure associated; No additional surgical procedure classified as a "failure".
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    General Health Status (SF-36)
    Time Frame
    24 months
    Title
    Pain Status (back pain, leg pain)
    Time Frame
    24 months
    Title
    Patient Satisfaction
    Time Frame
    24 months
    Title
    Patient Global Perceived Effect
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Has preoperative Oswestry score ≥ 30. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932). Requires fusion of a single level disc space from L1 to S1. Is at least 18 years of age, inclusive, at the time of surgery. 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. If of child-bearing potential, patient is non-pregnant,non-nursing,and agrees to use adequate contraception for 1 year following surgery. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form. Exclusion Criteria: Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level. Had previous spinal fusion surgical procedure at the involved level or an adjacent level. Requires spinal fusion at more than one lumbar level. 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. Has a documented history of osteopenia or osteomalacia. 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. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin). Has overt or active bacterial infection, either local or systemic. Has a documented titanium alloy allergy or intolerance. Is mentally incompetent. If questionable, obtain psychiatric consult. Has a 'Waddell Signs of Inorganic Behavior'score of 3 or greater. Is a prisoner. Is an alcohol and/or drug abuser as defined by currently undergoing treatment or alcohol and/or drug abuse. ls a tobacco user at the time of surgery. 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). Has a documented history of autoimmune disease ( e.g. Systemic Lupus Erythematosus or dermatomyositis). Has a history of exposure to implanted collagen or silicone implants. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen. 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. Has received any previous exposure to any/all BMP's of either human or animal extraction. Has a history of allergy to bovine products or a history of anaphylaxis. 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).

    12. IPD Sharing Statement

    Learn more about this trial

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

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