OsteoFlo HydroFiber
Conditions
Keywords
HydroFiber, fusion, lumbar, spine
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.
Interventions
DEVICEOsteoFlo HydroFiber
Observational study of subjects previously implanted with OsteoFlo HydroFiber.
Sponsors
SurGenTec LLC
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Quantitative Fusion | 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 | 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 | 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. |
| Rate of Qualitative Fusion | 6 months post-op | Presence of interbody and posterolateral bridging bone at the OsteoFlo HydroFiber treated level(s) as observed on CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Pain Improvement | From preop to study exit at 6- or 12-months postop | 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. |
| Rate of Disability Improvement | From preop to study exit at 6- or 12-months postop | Disability as measured using Oswestry Disability Index (ODI) questionnaire. |
Countries
United States
Outcome results
None listed