Can a new bone graft material improve spinal fusion outcomes?
NCT ID NCT07784673
First seen Aug 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This study looks at the safety and effectiveness of OsteoFlo HydroFiber, a material used to help bones fuse in the lower spine. Researchers will track 100 people who have already had this material implanted during lumbar spine surgery. They will check CT scans and X-rays to see if the bones are fusing properly and monitor for any complications. The goal is to gather real-world evidence on how well this material works in practice.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OsteoFlo HydroFiber, a bone graft material used in lumbar spine fusion surgery
- What this could lead to
- If successful, this study could provide evidence supporting the use of OsteoFlo HydroFiber as a safe and effective option for promoting spinal fusion, potentially improving surgical outcomes for patients with lumbar spine conditions.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by patient selection and other factors. The study's findings depend on real-world data, which can be variable, and the device's effectiveness may not be confirmed without randomized comparisons.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients that have previously undergone a lumbar fusion with OsteoFlo HydroFiber and at least 6 months postoperative.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Skeletally mature and age ≥ 18 years of age at the time of surgery. * Previously implanted with OsteoFlo HydroFiber in one or two contiguous vertebral level(s) in the lumbar (L1-S1) spine. * OsteoFlo HydroFiber was mixed with saline, blood, or bone marrow aspirate prior to use in the index procedure. * Be 6-months (180 -10/+30 days) post-surgery at the time of informed consent and at the6-month visit. * Be willing and able to comply with the study protocol requirements. * For prospective visit cohort, be willing to sign the study-specific Informed Consent Form. Exclusion Criteria: * Use of other bone graft substitute such as but not limited to, allograft, DBM, rhBMP-2 orsynthetic peptide enhanced graft as part of the index surgery. * Any lumbar fusion or total disc replacement (TDR) prior to the index procedure. * Any hardware failure prior to enrollment (e.g., cage, screw, or rod migration, loosening, or breakage) as determined by the core imaging lab. * BMI \>40. * Nicotine or recreational drug use at the time of the index surgery or during the healing period. * Significant metabolic bone disease (e.g., diagnosis of osteoporosis or osteomalacia). * Any active systemic or local spine infection at the time of surgery. * History of spinal infection at any spinal level prior to the index surgery. * Chronically taking medications that are known to interfere with bone healing (e.g., steroids) perioperatively and during the bone healing period. * Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period. * Currently enrolled in a competing research study. * Currently incarcerated. * Unable to comply with all postoperative imaging requirements (e.g., pregnant or nursing).
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duly Health and Care
Naperville, Illinois, 60540, United States
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Orthopaedics Northeast
Fort Wayne, Indiana, 46825, United States