NCT05299762 A Post Market Surveillance on INFUSE Bone Graft
| NCT ID | NCT05299762 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic Spinal and Biologics |
| Condition | Intervertebral Disc Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-08-10 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2022-08-10 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
Eligibility Criteria
Inclusion Criteria: * 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 * Is at least 18 years old at the time of informed consent Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05299762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intervertebral Disc Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05299762 currently recruiting?
Yes, NCT05299762 is actively recruiting participants. Contact the research team at michelle.kim@medtronic.com for enrollment information.
Where is the NCT05299762 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05299762 clinical trial?
NCT05299762 is sponsored by Medtronic Spinal and Biologics. The trial plans to enroll 600 participants.