A Post Market Surveillance on INFUSE Bone Graft
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INFUSE™ Bone Graft.
- Who it may be relevant to
- Registry conditions: Intervertebral Disc Degeneration, Spinal Fusion, Lumbar Disc Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device INFUSE™ 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.
Primary outcome measures
- Adverse device effects by 12 months post-surgery [Time frame: Surgery to 12 months]
- Fusion status at last assessment by 12 months post-surgery [Time frame: Surgery to 12 months]
Secondary outcome measures (4)
- Adverse events of interest up to 12 months post-surgery [Time frame: Surgery to 12 months]
- Clinical outcome (ODI) at 6 weeks, 3, 6, 12 months post-surgery [Time frame: Baseline (pre-op) to 12 months]
- Clinical outcome (VAS) at 6 weeks, 3, 6, 12 months post-surgery [Time frame: Baseline (pre-op) to 12 months]
- Rate of neurological success at 6 weeks, 3, 6, 12 months post-surgery [Time frame: Baseline (pre-op) to 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Chung-Ang Gwangmyeong Hospital — Seoul
Identifiers
NCT: NCT05299762 · MDT21006