Status:
COMPLETED
Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Degeneration of Lumbar Intervertebral Disc
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® ) for anterior lu...
Eligibility Criteria
Inclusion
- Has degenerative disc disease as noted by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies.
- Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.)
- Has single level symptomatic degenerative involvement from L2 to S1.
- Is between the ages of 18 and 65, inclusive, at the time of surgery.
- Is willing to comply with the study plan and sign the Patient Informed Consent Form.
- Has not responded to conservative treatment for a period of 5 months.
- If of child-bearing potential, subject is non-pregnant (documented by a negative Pregnancy test within 72 hours of surgery), non-nursing female who agrees to use adequate contraception for 16 weeks following surgery
Exclusion
- Has spinal condition other than symptomatic degenerative disc disease at the involved surgical level.
- Had previous anterior surgical procedures at the involved spinal level.
- Has a condition which requires postoperative medications that interfere with fusion such as steroids or nonsteroidal anti-inflammatory drugs. (This does not include low dose aspirin for prophylactic anticoagulation.)
- Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- Has circulatory problems, such as thrombophlebitis, lymphedema, or vascular deficiency at the implant site.
- Has symptomatic cardiac disease.
- Has presence of active malignancy or history of cancer in the past 5 years.
- Has overt or active infection.
- Is obese, i.e., weight greater than 40% over ideal for their age and height.
- Has fever (temperature \> 101°F oral).
- Has local inflammatory signs indicative of infection.
- Has a documented metal allergy or intolerance.
- Is involved in a worker's compensation or unresolved spinal litigation case.
- Is mentally incompetent (either documented or in the opinion of the investigator).
- Has psychogenic magnification of pain (in the opinion of the investigator).
- Is a prisoner.
- Is pregnant.
- Is an alcohol and/or substance abuser.
- Requires bone growth stimulation in the lumbar spine.
- Is a tobacco user at the time of surgery.
- Patient has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).
- Patient has a history of autoimmune disease (systemic lupus erythematosus or dermatomyositis).
- The subject has a history of exposure to injectable collagen implants.
- Patient's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- Patient 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/ACS implantation.
- Patient has received any previous exposure to BMP.
- The patient requires allograft or bone substitute as part of treatment.
- Patient has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
- Patient in the physician's opinion, would not be a good candidate for this surgical procedure.
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1999
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01491373
Start Date
January 1 1997
End Date
September 1 1999
Last Update
August 2 2013
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