An observational study in Intervertebral Disc Degeneration, Spinal Fusion and Lumbar Disc Disease, sponsored by Medtronic Spinal and Biologics. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Medtronic Spinal and Biologics (part of Medtronic) · Observational
Among 23 studies in Intervertebral Disc Degeneration by Medtronic Spinal and Biologics — 2 open to participants now, 2 under way, 1 of them phase 3. Intervertebral Disc Degeneration · Medtronic Spinal and Biologics.
Among the 23 studies in Intervertebral Disc Degeneration by Medtronic Spinal and Biologics, this one is the only one that started in 2022, is one of 5 observational ones, and was the 22nd registered.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 600 is above the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →2 of the 23 studies in Intervertebral Disc Degeneration by Medtronic Spinal and Biologics are open now, in 2 countries. Each count lists the studies.
Of the 60 Intervertebral Disc Degeneration studies recruiting now, 29 (48%) set no upper age limit and 16 (27%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 1 started in 2022.
Median enrollment 76 across the 18 interventional studies, 168 across the 5 observational. Of the 21 that completed or were terminated, 5 (24%) have results posted.
Medtronic Spinal and Biologics is the lead sponsor of 57 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Intervertebral Disc Degeneration by Medtronic Spinal and Biologics, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
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.
Patient should be considered for enrollment if he/she is to be treated with INFUSE™ Bone Graft.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Adverse device effects by 12 months post-surgery
Summarize adverse device effects
Time frame: 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
Time frame: Surgery to 12 months
Adverse events of interest up to 12 months post-surgery
Summarize adverse events of interest
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (pre-op) to 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Aug 2025, 36 months after the start.
Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intervertebral Disc Degeneration →
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