Intervertebral Disc DegenerationNCT05299762
A Post Market Surveillance on INFUSE Bone Graft
An observational study of Intervertebral Disc Degeneration and Spinal Fusion, run by Medtronic Spinal and Biologics at 1 site in South Korea.
Trial summary
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disc Degeneration, Spinal Fusion, Lumbar Disc Disease
- What is being tested?
- INFUSE™ Bone Graft
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2022to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient should be considered for enrollment if he/she is to be treated with INFUSE™ Bone Graft.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang Gwangmyeong Hospital
Seoul, 14353
Seungwon Park
About this study
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
Read the detailed 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.
- Being tested
- INFUSE™ Bone Graft
- Keywords
- INFUSE Bone Graft, Lumbar Interbody Fusion, Anterior Lumbar Interbody Fusion, Oblique Lumbar Interbody Fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFUSE™ Bone GraftDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: INFUSE™ Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse device effects by 12 months post-surgery
Summarize adverse device effects
Measured: 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
Measured: Surgery to 12 months
Secondary outcomes (4)
Adverse events of interest up to 12 months post-surgery
Summarize adverse events of interest
Measured: Surgery to 12 months
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.
Measured: Baseline (pre-op) to 12 months
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.
Measured: Baseline (pre-op) to 12 months
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).
Measured: Baseline (pre-op) to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start10 Aug 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299762
- Sponsor's protocol ID
- MDT21006
- Status last verified
- Mar 2025
- First submitted
- 20 Jan 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Surveillance on INFUSE Bone Graft
- ClinicalTrials.gov ID
- NCT05299762
- Acronym / sponsor ID
- MDT21006
- Keywords
- INFUSE Bone Graft, Lumbar Interbody Fusion, Anterior Lumbar Interbody Fusion, Oblique Lumbar Interbody Fusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with the INFUSE™ Bone Graft | – | Device: INFUSE™ Bone GraftPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient should be considered for enrollment if he/she is to be treated with INFUSE™ Bone Graft.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INFUSE™ Bone GraftMinistry 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. | Device | Patients treated with the INFUSE™ Bone Graft |
Primary outcome
Adverse device effects by 12 months post-surgery
Time frame: Surgery to 12 months
Summarize adverse device effects
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
4 secondary outcomes
Adverse events of interest up to 12 months post-surgery
Time frame: Surgery to 12 months
Clinical outcome (ODI) at 6 weeks, 3, 6, 12 months post-surgery
Time frame: Baseline (pre-op) to 12 months
Clinical outcome (VAS) at 6 weeks, 3, 6, 12 months post-surgery
Time frame: Baseline (pre-op) to 12 months
Rate of neurological success at 6 weeks, 3, 6, 12 months post-surgery
Time frame: Baseline (pre-op) to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration and Spinal Fusion, run by Medtronic Spinal and Biologics at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Kim (+82-3404-7756, michelle.kim@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse device effects by 12 months post-surgery (time frame: Surgery to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.