A Post Market Surveillance on INFUSE Bone Graft
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Spinal and Biologics
About this trial
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
Eligibility criteria
Qualifiers
Has degenerative disc disease and is indicated for lumbar interbody spine fusion from L2-S1 with INFUSE™ Bone Graft via ALIF or OLIF technique
Agrees to participate in the study and is able to understand and sign the Informed Consent
The procedure planned for the patient complies with the labeling of the devices that may be used in the surgical procedure
Has at least six months of nonoperative treatment prior to the study treatment
Disqualifiers
Has a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation
Has any active malignancy or undergoes treatment for a malignancy, or operative site is in the vicinity of a resected or extant tumor
Is skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure)
Is pregnant or lactating
Trial design
Treatments tested in this trial
- INFUSE™ Bone Graft
Treatment groups
600 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov