Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2022-08-10
2025-08-31
Brief Summary
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Detailed Description
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This study is supposed to be conducted during a period of 4 years with 600 or more cases after the product approval in Korea. According to the standard of care in Korea, the patients will be followed at least 12 months post-surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients treated with the INFUSE™ Bone Graft
Patients intended to be treated with the INFUSE™ Bone Graft are eligible for enrollment. The investigator screen candidate patients against inclusion/exclusion criteria and enroll a patient only when all inclusion/exclusion criteria meet, and the patient provide written informed consent.
INFUSE™ Bone Graft
Ministry of Food and Drug Safety (MFDS) has approved the INFUSE™ Bone Graft for anterior (ALIF) or oblique (OLIF) lumbar interbody spine fusion as a substitute for autogenous bone graft for patients with degenerative disc disease (DDD) who have had at least 6 months of non-operative treatment for this condition.
Interventions
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INFUSE™ Bone Graft
Ministry of Food and Drug Safety (MFDS) has approved the INFUSE™ Bone Graft for anterior (ALIF) or oblique (OLIF) lumbar interbody spine fusion as a substitute for autogenous bone graft for patients with degenerative disc disease (DDD) who have had at least 6 months of non-operative treatment for this condition.
Eligibility Criteria
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Inclusion Criteria
* 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
* Is at least 18 years old at the time of informed consent
Exclusion Criteria
* 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
* Has an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone
* The use of the Infuse™ Bone Graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine)
* Repeat applications of the Infuse™ Bone Graft component
* Has up to Grade 1 retrolisthesis
* Has hepatic or renal impairment
* Has metabolic bone disease
* Has autoimmune disease
* Has immunosuppressive disease or suppressed immune systems resulting from radiation therapy, chemotherapy, steroid therapy, or other treatments
* Is illiterate or vulnerable (e.g., the participant is incapable of judgment or is under tutelage) as per the investigator's assessment
* Concurrent participation in another clinical study that may confound study results
* Has a considerable risk for surgery
* Has a condition that could compromise study (e.g., mentally incompetent, alcohol or drug abuse) as per the investigator's assessment
18 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Locations
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Chung-Ang Gwangmyeong Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Seungwon Park
Role: primary
Other Identifiers
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MDT21006
Identifier Type: -
Identifier Source: org_study_id
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