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The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.
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Inclusion criteria
Degenerative lumbar spine condition:
Preoperative ODI score ≥40.
Preoperative pain score of ≥8 (out of 20) on the Preoperative Leg Pain Questionnaire.
Most inferior treated spinal level is able to accommodate an interbody fusion device.
≥21 years of age at the time of signing the informed consent.
Failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS).
Is willing and able to comply with the study plan and able to understand and sign the Subject Informed Consent Form.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
100 participants in 4 patient groups
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Central trial contact
Lauren Oien, MBA
Data sourced from clinicaltrials.gov
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