A Post Market Surveillance on INFUSE Bone Graft

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

Detailed Description
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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.

Official Title
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A Post Market Surveillance on INFUSE Bone Graft

Conditions
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Spinal Fusion, Intervertebral Disc Degeneration, Lumbar Disc Disease

Intervention / Treatment
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* Device: INFUSE™ Bone Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with the INFUSE™ Bone Graft<br>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. | Device: INFUSE™ Bone Graft<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse device effects by 12 months post-surgery | Summarize adverse device effects | Surgery to 12 months | 
| Fusion status at last assessment by 12 months post-surgery | Radiographic assessment of interbody fusion will be conducted using x-rays and/or CTs | Surgery to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of interest up to 12 months post-surgery | Summarize adverse events of interest | Surgery to 12 months | 
| Clinical outcome (ODI) at 6 weeks, 3, 6, 12 months post-surgery | Characterize changes in Oswestry Disability Index (ODI) over time. ODI evaluates how pain is affecting the patient's ability to manage in everyday life, rated on a 0 to 5 scale (higher rating represents greater disability). Improvement of ODI is defined as a decrease in score compared to baseline. | Baseline (pre-op) to 12 months | 
| Clinical outcome (VAS) at 6 weeks, 3, 6, 12 months post-surgery | Characterize changes in Visual Analogue Scale (VAS) for back and leg pain over time. VAS evaluates the magnitude of leg and back pain, rated on a 0 to 10 scale (higher rating represents greater pain). Improvement of VAS is defined as a decrease in score compared to baseline. | Baseline (pre-op) to 12 months | 
| Rate of neurological success at 6 weeks, 3, 6, 12 months post-surgery | Characterizes changes in neurological status over time. Neurological status is assessed in four sections: motor, sensory, reflexes, and straight leg raising. Following scales were used to evaluate neurological status: motor function (using 0-5 scores; 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength), sensory function (using 0-2 scores; 0 = Absent, 1 = Impaired, 2 = Normal), reflexes (using 0-2 scores; 0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), and straight leg raise (1 = Positive, 2 = Negative). Overall neurological success will be defined as maintenance or improvement in all sections (motor, sensory, reflexes, and straight leg raising) for the time period evaluated (each element must remain the same or improve). | Baseline (pre-op) to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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INFUSE Bone Graft, Lumbar Interbody Fusion, Anterior Lumbar Interbody Fusion, Oblique Lumbar Interbody Fusion