Back to resultsPilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
Primary Purpose
Degenerative Disc Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rhBMP-2/BCP device
rhBMP-2/BCP device
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Spinal degeneration
Eligibility Criteria
Inclusion Criteria:
- Subject has radiographically documented spinal degeneration with instability as documented by the presence of translation >= 4mm or angulation >= 5°.
- Subject has intractable back pain which does not respond to conservative treatment and in the investigator's opinion, requires surgical spinal fusion.
- Subject's pain is predominantly associated with the back.
- Subject has only one level involvement at L3-L4, L4-L5, or L5-S1.
- Subject is 18 years of age or greater at the time consent is given to participate in the study.
- Subject is willing to comply with the study plan and sign the informed consent.
- Subject is male or a non-pregnant, non-nursing female. All females of child-bearing age must agree to use adequate contraception for a period of no less than 16 weeks following surgery.
Exclusion Criteria:
- Subject has primary spinal diagnosis of a disorder other than spinal degeneration with instability at the involved surgical level.
- Subject has spinal stenosis or condition which requires a full laminectomy procedure.
- Subject has had a previous fusion, discectomy or laminectomy procedure at L3-L4, L4-L5 or L5-S1.
- Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids, methotrexate) or has a condition which requires postoperative medications that interfere with fusion (e.g., steroids, nonsteroidal antiinflammatory drugs, or methotrexate).
- Subject has overt or active infection near the operative spinal region.
- Subject has active systemic infection.
- Subject has history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- Subject's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
- Subject 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.
- The subject requires electrical bone growth stimulation, allograft, or bone substitute as part of treatment.
- Subject has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers Danlos syndrome, or osteogenesis imperfecta).
- Subject has a known diagnosis of diabetes which requires treatment with medication.
- Subject has received previous radiation therapy at the site to be fused.
- Subject is unwilling to return for required follow-up visits.
- Subject is a prisoner.
- Subject has insufficient bone mass which precludes surgery (e.g., severe osteopenia or osteoporosis).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
Each patient will receive 15mg of rhBMP-2 in rhBMP-2/BCP device and implant unilaterally during a posterolateral spinal fusion procedure. The contralateral side was fused using standard fusion techniques with autograft bone.
Each patient will receive 20mg of rhBMP-2 in rhBMP-2/BCP device and implant bilaterally.
Outcomes
Primary Outcome Measures
Fusion Status
Fusion will be met all of the following criteria:
Evidence of bridging trabecular bone;
Angular motion < 5°;
Translational motion <= 3mm;
No radiolucent lines spanning the entire fusion mass.
Secondary Outcome Measures
Oswestry Low Back Pain Disability Questionnaire Status
Neuro/Functional Status
A neurological functional questionnaire will be completed by patients prior to surgery and postoperative, including three questions pertaining to pain (severity of pain, location of pain, and leg pain side), and four questions associated with functional activities (recreational activity level, putting on shoes and socks, squatting, occupation activity level). Success will be based on a maintenance or improvement from the preoperative condition for the functional components, except that severity of pain success will be based on an improvement of at least one point on the five point scale.
Neurological Status
A scale will be used to measure neurological status. This scale focuses on reflexes, sensory, motor function, and the degree of straight leg raise reproducing pain. All of these elements are combined to give an overall score. Success will be based on a maintenance or improvement in all categories from the preoperative condition.
General Health Status (SF-36)
Full Information
NCT ID
NCT01495234
First Posted
December 12, 2011
Last Updated
May 16, 2023
Sponsor
Medtronic Spinal and Biologics
1. Study Identification
Unique Protocol Identification Number
NCT01495234
Brief Title
Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
Official Title
A Pilot Investigation of Recombinant Human Bone Morphogenetic Protein- 2/Biphasic Calcium Phosphate in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1996 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
June 2001 (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
This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring spinal fusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
Spinal degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Each patient will receive 15mg of rhBMP-2 in rhBMP-2/BCP device and implant unilaterally during a posterolateral spinal fusion procedure. The contralateral side was fused using standard fusion techniques with autograft bone.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Each patient will receive 20mg of rhBMP-2 in rhBMP-2/BCP device and implant bilaterally.
Intervention Type
Device
Intervention Name(s)
rhBMP-2/BCP device
Other Intervention Name(s)
Recombinant human bone morphogenetic protein-2
Intervention Description
The rhBMP-2/BCP device 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 device
Other Intervention Name(s)
recombinant human Bone Morphogenetic Protein-2
Intervention Description
The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
Primary Outcome Measure Information:
Title
Fusion Status
Description
Fusion will be met all of the following criteria:
Evidence of bridging trabecular bone;
Angular motion < 5°;
Translational motion <= 3mm;
No radiolucent lines spanning the entire fusion mass.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Oswestry Low Back Pain Disability Questionnaire Status
Time Frame
12 month
Title
Neuro/Functional Status
Description
A neurological functional questionnaire will be completed by patients prior to surgery and postoperative, including three questions pertaining to pain (severity of pain, location of pain, and leg pain side), and four questions associated with functional activities (recreational activity level, putting on shoes and socks, squatting, occupation activity level). Success will be based on a maintenance or improvement from the preoperative condition for the functional components, except that severity of pain success will be based on an improvement of at least one point on the five point scale.
Time Frame
12 month
Title
Neurological Status
Description
A scale will be used to measure neurological status. This scale focuses on reflexes, sensory, motor function, and the degree of straight leg raise reproducing pain. All of these elements are combined to give an overall score. Success will be based on a maintenance or improvement in all categories from the preoperative condition.
Time Frame
12 month
Title
General Health Status (SF-36)
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has radiographically documented spinal degeneration with instability as documented by the presence of translation >= 4mm or angulation >= 5°.
Subject has intractable back pain which does not respond to conservative treatment and in the investigator's opinion, requires surgical spinal fusion.
Subject's pain is predominantly associated with the back.
Subject has only one level involvement at L3-L4, L4-L5, or L5-S1.
Subject is 18 years of age or greater at the time consent is given to participate in the study.
Subject is willing to comply with the study plan and sign the informed consent.
Subject is male or a non-pregnant, non-nursing female. All females of child-bearing age must agree to use adequate contraception for a period of no less than 16 weeks following surgery.
Exclusion Criteria:
Subject has primary spinal diagnosis of a disorder other than spinal degeneration with instability at the involved surgical level.
Subject has spinal stenosis or condition which requires a full laminectomy procedure.
Subject has had a previous fusion, discectomy or laminectomy procedure at L3-L4, L4-L5 or L5-S1.
Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids, methotrexate) or has a condition which requires postoperative medications that interfere with fusion (e.g., steroids, nonsteroidal antiinflammatory drugs, or methotrexate).
Subject has overt or active infection near the operative spinal region.
Subject has active systemic infection.
Subject has history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
Subject's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
Subject 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.
The subject requires electrical bone growth stimulation, allograft, or bone substitute as part of treatment.
Subject has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers Danlos syndrome, or osteogenesis imperfecta).
Subject has a known diagnosis of diabetes which requires treatment with medication.
Subject has received previous radiation therapy at the site to be fused.
Subject is unwilling to return for required follow-up visits.
Subject is a prisoner.
Subject has insufficient bone mass which precludes surgery (e.g., severe osteopenia or osteoporosis).
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
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