OsteoFlo HydroFiber Ambispective Evaluation

NCT07784673 | Enrolling By Invitation FDA Device

• 1 other identifier: SAON-2026-AHF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

OsteoFlo HydroFiber

Keywords

HydroFiber; fusion; lumbar; spine

Outcome Measures

Primary Outcomes (4)

• Rate of Qualitative Fusion

  Presence of interbody and posterolateral bridging bone at the OsteoFlo HydroFiber treated level(s) as observed on CT scan

  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.

  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.

  6 months post-op

• Incidence of Serious Adverse Events

  Freedom from OsteoFlo HydroFiber device-related serious adverse events as adjudicated by an independent reviewer.

  From index procedure to study exit at 6- or 12-months postop

Secondary Outcomes (2)

• Rate of Pain Improvement

  From preop to study exit at 6- or 12-months postop

• Rate of Disability Improvement

  From preop to study exit at 6- or 12-months postop

Study Arms (1)

Lumbar

Previously implanted with the OsteoFlo HydroFiber in one or two contiguous vertebral levels of the lumbar spine (L1-S1).

Device: OsteoFlo HydroFiber

Interventions

OsteoFlo HydroFiber DEVICE

Observational study of subjects previously implanted with OsteoFlo HydroFiber.

Lumbar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have previously undergone a lumbar fusion with OsteoFlo HydroFiber and at least 6 months postoperative.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• SurGenTec LLC: lead

Study Sites (2)

Duly Health and Care

Naperville, Illinois, 60540, United States

Location

Orthopaedics Northeast

Fort Wayne, Indiana, 46825, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

US (2)