A Post Market Surveillance on INFUSE Bone Graft

Last updated: March 17, 2025
Sponsor: Medtronic Spinal and Biologics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Surgery

Spondylolisthesis

Spine Athroplasty

Treatment

INFUSE™ Bone Graft

Clinical Study ID

NCT05299762
MDT21006
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has degenerative disc disease and is indicated for lumbar interbody spine fusionfrom 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 InformedConsent

  • The procedure planned for the patient complies with the labeling of the devices thatmay 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

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 siteis in the vicinity of a resected or extant tumor

  • Is skeletally immature (<18 years of age or no radiographic evidence of epiphysealclosure)

  • 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 thelower 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 radiationtherapy, chemotherapy, steroid therapy, or other treatments

  • Is illiterate or vulnerable (e.g., the participant is incapable of judgment or isunder 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 ordrug abuse) as per the investigator's assessment

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: INFUSE™ Bone Graft
Phase:
Study Start date:
August 10, 2022
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Chung-Ang Gwangmyeong Hospital

    Seoul, 14353
    Korea, Republic of

    Active - Recruiting

  • Wooridul Spine Hospital

    Seoul, 06068
    Korea, Republic of

    Active - Recruiting

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