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NCT Number: NCT05299762

A Post Market Surveillance on INFUSE Bone Graft

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

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Key information

Conditions

Intervertebral Disc Degeneration Bone Diseases Intervertebral disc disease Lumbar Disc Disease Musculoskeletal Diseases Spinal Diseases Spinal Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chung-Ang Gwangmyeong Hospital

Seoul, 14353, South Korea

Location status: Recruiting

Location contact

Seungwon Park

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adverse device effects by 12 months post-surgery

    Time frame: Surgery to 12 months

    Summarize adverse device effects

  2. Fusion status at last assessment by 12 months post-surgery

    Time frame: Surgery to 12 months

    Radiographic assessment of interbody fusion will be conducted using x-rays and/or CTs

Secondary outcomes

  1. Adverse events of interest up to 12 months post-surgery

    Time frame: Surgery to 12 months

    Summarize adverse events of interest

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

    Time frame: Baseline (pre-op) to 12 months

    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.

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

    Time frame: Baseline (pre-op) to 12 months

    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.

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

    Time frame: Baseline (pre-op) to 12 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Kim

CONTACT

[email protected]

+82-3404-7756

Sponsors and collaborators

Lead sponsor

Medtronic Spinal and Biologics

Industry

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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