Status:
COMPLETED
Clinical Study of rhBMP-2/BCP With 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
This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the patients with degenerative disc disease.
Eligibility Criteria
Inclusion
- 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 \[leg, back, or symptoms in the sciatic nerve distribution\], 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° translation \>= 4mm, 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).
- Has one or two adjacent levels from L1 to S1 requiring fusion.
- 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, agrees to not become pregnant for 1 year 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 Grade 1 spondylolisthesis at the involved levels.
- Had previous spinal fusion surgical procedure at the involved levels.
- Has a condition that 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 or prior history of malignancy (except for basal cell carcinoma of the skin).
- 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 that 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 BMP's 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 :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT01494454
Start Date
August 1 1999
End Date
November 1 2007
Last Update
May 17 2023
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