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This study aims to evaluate the safety and effectiveness of INFUSE⢠Bone Graft in the real-world setting in Korea.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with the INFUSE⢠Bone Graft | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INFUSE⢠Bone Graft | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient should be considered for enrollment if he/she is to be treated with INFUSE⢠Bone Graft.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Kim | Contact | +82-3404-7756 | michelle.kim@medtronic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang Gwangmyeong Hospital | Recruiting | Seoul | 14353 | South Korea |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| C535531 | Intervertebral disc disease |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |