Status:
COMPLETED
Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 fusio...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01494441
Start Date
May 1 1999
End Date
March 1 2003
Last Update
May 17 2023
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