Clinical trial NCT05299762: A Post Market Surveillance on INFUSE Bone Graft
Official title: A Post Market Surveillance on INFUSE Bone Graft
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intervertebral Disc Degeneration
Spinal Fusion
Lumbar Disc Disease
Keywords: INFUSE Bone Graft
Lumbar Interbody Fusion
Anterior Lumbar Interbody Fusion
Oblique Lumbar Interbody Fusion
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient should be considered for enrollment if he/she is to be treated with INFUSE™ Bone Graft.

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

Detailed 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.

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

Primary outcomes:
measure: Adverse device effects by 12 months post-surgery
timeFrame: Surgery to 12 months
measure: Fusion status at last assessment by 12 months post-surgery
timeFrame: Surgery to 12 months
Secondary outcomes:
measure: Adverse events of interest up to 12 months post-surgery
timeFrame: Surgery to 12 months
measure: Clinical outcome (ODI) at 6 weeks, 3, 6, 12 months post-surgery
timeFrame: Baseline (pre-op) to 12 months
measure: Clinical outcome (VAS) at 6 weeks, 3, 6, 12 months post-surgery
timeFrame: Baseline (pre-op) to 12 months
measure: Rate of neurological success at 6 weeks, 3, 6, 12 months post-surgery
timeFrame: Baseline (pre-op) to 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Gwangmyeong Hospital
Study officials:
References: