OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 12, 2017

Detailed Description

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.

Interventions

  • Device: OsseoScrew Spinal Fixation System
    • Surgical intervention

Arms, Groups and Cohorts

  • OsseoScrew
    • Test Product: OsseoScrew Spinal Fixation System
  • Fenestrated Screw
    • Control Product: Any commercially available fenestrated screw system augmented with PMMA

Clinical Trial Outcome Measures

Primary Measures

  • Safety Endpoint: Rate of device-related or PMMA-related complications
    • Time Frame: 24 months
    • 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.
  • Efficacy Endpoint: Successful radiographic fusion
    • Time Frame: 24 months
    • Presence of continuous bridging bone across the implant

Secondary Measures

  • Oswestry Disability Index
    • Time Frame: 24 months
    • 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.
  • Visual Analogue Scale for back pain
    • Time Frame: 24 months
    • 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.
  • Adverse events
    • Time Frame: 24 months
    • Adverse event rates

Participating in This Clinical Trial

Inclusion Criteria

1. ≥ 18 years of age 2. Spinal instability or deformity requiring fusion with instrumentation 3. Osteopenia defined as (T-Score of less than -1.0) 4. No response to nonoperative treatment modalities preceding enrollment. 5. 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:

1. Active systemic or local infection 2. A life expectancy less than the study duration 3. Autoimmune disorders 4. Currently an alcohol, solvent, or drug abuser 5. Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements 6. History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alphatec Spine, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bita Ghadimi, Study Director, Alphatec Spine, Inc.

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