A Post Market Surveillance on INFUSE Bone Graft

NCT05299762 | Recruiting FDA Device

• 1 other identifier: MDT21006
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intervertebral Disc Degeneration; Spinal Fusion; Lumbar Disc Disease

Keywords

INFUSE Bone Graft; Lumbar Interbody Fusion; Anterior Lumbar Interbody Fusion; Oblique Lumbar Interbody Fusion

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Adverse events of interest up to 12 months post-surgery

  Surgery to 12 months

• Clinical outcome (ODI) at 6 weeks, 3, 6, 12 months post-surgery

  Baseline (pre-op) to 12 months

• Clinical outcome (VAS) at 6 weeks, 3, 6, 12 months post-surgery

  Baseline (pre-op) to 12 months

• Rate of neurological success at 6 weeks, 3, 6, 12 months post-surgery

  Baseline (pre-op) to 12 months

Study Arms (1)

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.

Device: INFUSE™ Bone Graft

Interventions

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.

Patients treated with the INFUSE™ Bone Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient should be considered for enrollment if he/she is to be treated with INFUSE™ Bone Graft.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (1)

Chung-Ang Gwangmyeong Hospital

Seoul, 14353, South Korea

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral disc disease

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Michelle Kim

CONTACT

+82-3404-7756; michelle.kim@medtronic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: March 29, 2022
• Study Start: August 10, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)