Intervertebral Disc Degeneration, Lumbar Disc Disease, Spinal Fusion
Conditions
Keywords
INFUSE Bone Graft, Lumbar Interbody Fusion, Anterior Lumbar Interbody Fusion, Oblique Lumbar Interbody Fusion
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.
Interventions
DEVICEINFUSE™ 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.
Sponsors
Medtronic Spinal and Biologics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse device effects by 12 months post-surgery | Surgery to 12 months | Summarize adverse device effects |
| Fusion status at last assessment by 12 months post-surgery | Surgery to 12 months | Radiographic assessment of interbody fusion will be conducted using x-rays and/or CTs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of interest up to 12 months post-surgery | Surgery to 12 months | Summarize adverse events of interest |
| Clinical outcome (ODI) at 6 weeks, 3, 6, 12 months post-surgery | Baseline (pre-op) to 12 months | 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. |
| Clinical outcome (VAS) at 6 weeks, 3, 6, 12 months post-surgery | Baseline (pre-op) to 12 months | 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. |
| Rate of neurological success at 6 weeks, 3, 6, 12 months post-surgery | Baseline (pre-op) to 12 months | 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). |
Countries
South Korea
Contacts
Primary ContactMichelle Kim
Outcome results
None listed