A Post Market Surveillance on INFUSE Bone Graft
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Spinal and Biologics
About this trial
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patient should be considered for enrollment if he/she is to be treated with INFUSE™ Bone Graft.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
INFUSE™ Bone Graft
DeviceMinistry 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.
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Patients treated with the INFUSE™ Bone Graft1 intervention
Trial outcomes
Primary outcomes
1
Adverse device effects by 12 months post-surgery
Summarize adverse device effects
Time frame
Surgery to 12 months2
Fusion status at last assessment by 12 months post-surgery
Radiographic assessment of interbody fusion will be conducted using x-rays and/or CTs
Time frame
Surgery to 12 monthsSecondary outcomes
1
Adverse events of interest up to 12 months post-surgery
Summarize adverse events of interest
Time frame
Surgery to 12 months2
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.
Time frame
Baseline (pre-op) to 12 months3
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.
Time frame
Baseline (pre-op) to 12 months4
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).
Time frame
Baseline (pre-op) to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov