OsteoFlo HydroFiberNCT07784673
OsteoFlo HydroFiber Ambispective Evaluation
An observational study of OsteoFlo HydroFiber, run by SurGenTec LLC at 2 sites in United States.
Trial summary
The goal of this observational, ambispective study is to collect real world patient outcomes to characterize the safety and effectiveness of OsteoFlo HydroFiber when used to promote fusion in the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OsteoFlo HydroFiber
- What is being tested?
- OsteoFlo HydroFiber
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2026to 1 Feb 2027
- 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: Patients that have previously undergone a lumbar fusion with OsteoFlo HydroFiber and at least 6 months postoperative.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Orthopaedics Northeast
Fort Wayne, Indiana, 46825
Duly Health and Care
Naperville, Illinois, 60540
About this study
Official title: An Ambispective Safety and Effectiveness Evaluation of OsteoFlo HydroFiber
The goal of this observational, ambispective study is to collect real world patient outcomes to characterize the safety and effectiveness of OsteoFlo HydroFiber when used to promote fusion in the lumbar spine.
- Conditions
- OsteoFlo HydroFiber
- Being tested
- OsteoFlo HydroFiber
- Keywords
- HydroFiber, fusion, lumbar, spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteoFlo HydroFiberDevice
Observational study of subjects previously implanted with OsteoFlo HydroFiber.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar | Previously implanted with the OsteoFlo HydroFiber in one or two contiguous vertebral levels of the lumbar spine (L1-S1). Receives: Device: OsteoFlo HydroFiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Qualitative Fusion
Presence of interbody and posterolateral bridging bone at the OsteoFlo HydroFiber treated level(s) as observed on CT scan
Measured: 6 months post-op
Rate of Quantitative Fusion
Intervertebral angular motion at the OsteoFlo HydroFiber treated level(s) as measured on dynamic flexion and extension radiographs.
Measured: 6 months post-op
Incidence of Implant Quantitative Condition
Condition of interbody, hardware, and graft of the OsteoFlo HydroFiber treated level(s) as on dynamic flexion and extension radiographs and CT scan.
Measured: 6 months post-op
Incidence of Serious Adverse Events
Freedom from OsteoFlo HydroFiber device-related serious adverse events as adjudicated by an independent reviewer.
Measured: From index procedure to study exit at 6- or 12-months postop
Secondary outcomes (2)
Rate of Pain Improvement
Back, right and left leg pain as measured on a Visual Analog Scale or Numerical Rating Scale where zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: From preop to study exit at 6- or 12-months postop
Rate of Disability Improvement
Disability as measured using Oswestry Disability Index (ODI) questionnaire.
Measured: From preop to study exit at 6- or 12-months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoFlo HydroFiberStudies 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SurGenTec LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784673
- Sponsor's protocol ID
- SAON-2026-AHF
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: IPD sharing has not yet been determined. A decision regarding whether individual participant data will be made available will be made at a later date, taking into consideration participant privacy, confidentiality, applicable regulations, and study requirements. If IPD sharing is permitted, the specific data to be shared and the conditions for access will be defined at that time.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ambispective Safety and Effectiveness Evaluation of OsteoFlo HydroFiber
- ClinicalTrials.gov ID
- NCT07784673
- Acronym / sponsor ID
- SAON-2026-AHF
- Conditions
- OsteoFlo HydroFiber
- Keywords
- HydroFiber, fusion, lumbar, spine
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SurGenTec LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 Aug 2026 (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.
The goal of this observational, ambispective study is to collect real world patient outcomes to characterize the safety and effectiveness of OsteoFlo HydroFiber when used to promote fusion in the lumbar spine.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar | – | Device: OsteoFlo HydroFiberPreviously implanted with the OsteoFlo HydroFiber in one or two contiguous vertebral levels of the lumbar spine (L1-S1). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have previously undergone a lumbar fusion with OsteoFlo HydroFiber and at least 6 months postoperative.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| OsteoFlo HydroFiberObservational study of subjects previously implanted with OsteoFlo HydroFiber. | Device | Lumbar |
Primary outcome
Rate of Qualitative Fusion
Time frame: 6 months post-op
Presence of interbody and posterolateral bridging bone at the OsteoFlo HydroFiber treated level(s) as observed on CT scan
Rate of Quantitative Fusion
Time frame: 6 months post-op
Intervertebral angular motion at the OsteoFlo HydroFiber treated level(s) as measured on dynamic flexion and extension radiographs.
Incidence of Implant Quantitative Condition
Time frame: 6 months post-op
Condition of interbody, hardware, and graft of the OsteoFlo HydroFiber treated level(s) as on dynamic flexion and extension radiographs and CT scan.
Incidence of Serious Adverse Events
Time frame: From index procedure to study exit at 6- or 12-months postop
Freedom from OsteoFlo HydroFiber device-related serious adverse events as adjudicated by an independent reviewer.
2 secondary outcomes
Rate of Pain Improvement
Time frame: From preop to study exit at 6- or 12-months postop
Rate of Disability Improvement
Time frame: From preop to study exit at 6- or 12-months postop
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 19 Oct 2026.
- Individual participant dataSharing planned: Undecided. IPD sharing has not yet been determined. A decision regarding whether individual participant data will be made available will be made at a later date, taking into consideration participant privacy, confidentiality, applicable regulations, and study requirements. If IPD sharing is permitted, the specific data to be shared and the conditions for access will be defined at that time.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OsteoFlo HydroFiber, run by SurGenTec LLC at 2 sites in United States.
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 6 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Qualitative Fusion (time frame: 6 months post-op). The study lists 4 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 19 Oct 2026.