A Post Market Surveillance on INFUSE Bone Graft

Medtronic

Status: Enrolling

Conditions: Intervertebral Disc Degeneration; Spinal Fusion; Lumbar Disc Disease

Treatments: Device: INFUSE™ Bone Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT05299762

MDT21006

Details and patient eligibility

About

This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.

Full description

This study is a prospective, observational, multi-center, post-market surveillance to collect patient data regarding on-label use of INFUSE™ Bone Graft for lumbar fusion via ALIF or OLIF. Commercially available device will be used within its intended use.

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Patients treated with the INFUSE™ Bone Graft

Description:

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.

Treatment:

Device: INFUSE™ Bone Graft