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Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

Primary Purpose

Degenerative Disc Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rhBMP-2/BCP
rhBMP-2/BCP/TSRH® Spinal System
Autograft/TSRH® 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 lumbar degenerative disc disease

Eligibility Criteria

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

Inclusion Criteria:

  1. Has degenerative disc diseases 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° and/or translation > 4 mm, 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. 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 at least 6 months.
  7. If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks 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 Grade1 or less spondylolisthesis at the involved level.
  2. Had previous spinal fusion surgical procedure at the involved level.
  3. Require spinal fusion at more than one lumbar level.
  4. Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
  5. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
  6. Has presence of active malignancy.
  7. Has overt or active bacterial infection, either local or systemic.
  8. Is grossly obese, i.e., weight > 40% over ideal for their age and height.
  9. Has fever ( temperature >101°F oral) at the time of surgery.
  10. Has a documented titanium alloy allergy or intolerance.
  11. Is mentally incompetent. If questionable, obtain psychiatric consult.
  12. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
  13. Is a prisoner.
  14. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
  15. Is a tobacco user at the time of surgery.
  16. Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., NSAIDS, steroids or methotrexate).
  17. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
  18. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
  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/BCP implantation.
  20. Has received any previous exposure to any/all BMPs of either human or animal extraction.
  21. Has a history of severe allergy (anaphylaxis).
  22. Has 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 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    rhBMP-2/BCP

    rhBMP-2/BCP/TSRH® Spinal System

    Autograft/TSRH® Spinal System

    Arm Description

    Outcomes

    Primary Outcome Measures

    Fusion
    Fusion is defined as: Evidence of bridging trabecular bone. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs 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; Absence of radiolucent lines completely through the fusion mass.
    Pain/Disability Status
    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 Success
    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
    General Health Status (SF-36)
    Pain Status (back pain, leg pain)
    Patient Satisfaction
    Patient Global Perceived Effect
    Overall Success

    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
    NCT01494441
    Brief Title
    Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
    Official Title
    A Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With or Without the TSRH® 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
    May 1999 (undefined)
    Primary Completion Date
    March 2003 (Actual)
    Study Completion Date
    March 2003 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft 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
    lumbar 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
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    rhBMP-2/BCP
    Arm Type
    Experimental
    Arm Title
    rhBMP-2/BCP/TSRH® Spinal System
    Arm Type
    Experimental
    Arm Title
    Autograft/TSRH® Spinal System
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    rhBMP-2/BCP
    Other Intervention Name(s)
    recombinant human Bone Morphogenetic Protein-2, biphasic calcium phosphate
    Intervention Description
    The rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
    Intervention Type
    Device
    Intervention Name(s)
    rhBMP-2/BCP/TSRH® Spinal System
    Other Intervention Name(s)
    recombinant human Bone Morphogenetic Protein-2, biphasic calcium phosphate
    Intervention Description
    rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System.
    Intervention Type
    Device
    Intervention Name(s)
    Autograft/TSRH® Spinal System
    Other Intervention Name(s)
    Autograft
    Intervention Description
    The control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System.
    Primary Outcome Measure Information:
    Title
    Fusion
    Description
    Fusion is defined as: Evidence of bridging trabecular bone. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs 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; Absence of radiolucent lines completely through the fusion mass.
    Time Frame
    24 month
    Title
    Pain/Disability Status
    Description
    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
    Time Frame
    24 month
    Secondary Outcome Measure Information:
    Title
    Neurological Status Success
    Description
    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.
    Time Frame
    24 month
    Title
    Hip (Donor Site) Pain
    Time Frame
    24 month
    Title
    General Health Status (SF-36)
    Time Frame
    24 month
    Title
    Pain Status (back pain, leg pain)
    Time Frame
    24 month
    Title
    Patient Satisfaction
    Time Frame
    24 month
    Title
    Patient Global Perceived Effect
    Time Frame
    24 month
    Title
    Overall Success
    Time Frame
    24 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has degenerative disc diseases 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° and/or translation > 4 mm, based on Flex/Ext 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 at least 6 months. If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks 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 Grade1 or less spondylolisthesis at the involved level. Had previous spinal fusion surgical procedure at the involved level. Require spinal fusion at more than one lumbar level. Has a condition which requires postoperative medications that interfere with fusion, such as steroids. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated. Has presence of active malignancy. Has overt or active bacterial infection, either local or systemic. Is grossly obese, i.e., weight > 40% over ideal for their age and height. Has fever ( temperature >101°F oral) at the time of surgery. 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 for alcohol and/or drug usage. Is 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., NSAIDS, steroids or methotrexate). Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis). Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins). 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. Has received any previous exposure to any/all BMPs of either human or animal extraction. Has a history of severe allergy (anaphylaxis). Has 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

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    Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

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