OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

Study Overview
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Brief Summary
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The purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The study was designed to compare the safety and efficacy of OsseoScrew compared to any other commercially available fenestrated pedicle screw system augmented with PMMA for posterior spinal fixation after surgical correction of spinal deformity or pathology.

Detailed Description
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This was a randomized, open-label, controlled, multi-center study in which patients were randomized in a 1:1 ratio to receive either the OsseoScrew or any commercially available fenestrated screw augmented with polymethylmethacrylate (PMMA) (Control group) for posterior spinal fixation after surgical correction of spinal deformity or pathology. The study was planned to include up to 150 skeletally mature patients with spinal instability and osteopenia at up to 10 sites. Patients were to return postoperatively at 6 weeks (± 2 weeks) and at 6, 12, and 24 months (± 2 months) for assessments.

Official Title
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Expandable Pedicle Screws Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (PMMA): Complications and Clinical Outcomes in Patients With Osteoporosis or Poor Bone Quality

Conditions
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Osteoporosis, Poor Bone Quality

Intervention / Treatment
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* Device: OsseoScrew Spinal Fixation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Spinal instability or deformity requiring fusion with instrumentation Osteopenia defined as (T-Score of less than -1.0) No response to nonoperative treatment modalities preceding enrollment. Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study and to return for scheduled follow-up evaluations Exclusion Criteria: Active systemic or local infection A life expectancy less than the study duration Autoimmune disorders Currently an alcohol, solvent, or drug abuser Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OsseoScrew<br>Test Product: OsseoScrew Spinal Fixation System | Device: OsseoScrew Spinal Fixation System<br>* Surgical intervention<br>|
| Fenestrated Screw<br>Control Product: Any commercially available fenestrated screw system augmented with PMMA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoint: Rate of device-related or PMMA-related complications | The proportion of patients who were free from device-related or PMMA-related complications leading to revision, supplemental fixation, non-elective removal, or reoperation throughout the study. Complications included, but were not limited to device or PMMA fracture, device or PMMA-related loosening, device or PMMA-related device disassembly, device migration or PMMA extravasation. | 24 months | 
| Efficacy Endpoint: Successful radiographic fusion | Presence of continuous bridging bone across the implant | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | This is a measure of the patient's self reported permanent functional disability. Each section is scored on a 1-5 scale with 5 representing the greatest disability. | 24 months | 
| Visual Analogue Scale for back pain | This is a measure of the characteristic or attitude that is believed to range across a continuum of values to measure pain intensity. The range of score is from 0 - 100. The patient marks on the line the point that they feel represents their perception of their current state. A higher score indicates greater pain intensity. | 24 months | 
| Adverse events | Adverse event rates | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopenia, Stenosis, Instability, Tumor