A Post Market Surveillance on INFUSE Bone Graft

Spinal Fusion Clinical Trial

Official title:

A Post Market Surveillance on INFUSE Bone Graft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299762
• Other study ID #: MDT21006
• Status: Recruiting
• Start date: August 10, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Medtronic Spinal and Biologics
• Contact: Michelle Kim
• Phone: +82-3404-7756
• Email: michelle.kim[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Disc Disease
• Spinal Fusion

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang Gwangmyeong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse device effects by 12 months post-surgery	Summarize adverse device effects	Surgery to 12 months
Primary	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	Adverse events of interest up to 12 months post-surgery	Summarize adverse events of interest	Surgery to 12 months
Secondary	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
Secondary	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
Secondary	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