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
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring lumbar degenerative disc disease
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).
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
NCT ID
NCT01494441
First Posted
December 12, 2011
Last Updated
May 16, 2023
Sponsor
Medtronic Spinal and Biologics
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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