OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

Completed

• Conditions: Poor Bone Quality; Osteoporosis
• Interventions: Device: OsseoScrew Spinal Fixation System

• Registration Number: NCT01613144
• Lead Sponsor: Alphatec Spine, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-07
• Primary Completion: 2017-02-12
• Study Completion: 2017-11-08
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OsseoScrew	OsseoScrew Spinal Fixation System	Test Product: OsseoScrew Spinal Fixation System

Primary Outcome Measures

Name	Time	Method
Safety Endpoint: Rate of device-related or PMMA-related complications	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	24 months	Presence of continuous bridging bone across the implant

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	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	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	24 months	Adverse event rates

Trial Locations

Locations (10)

ULB Hopital Erasme; 🇧🇪 Bruxelles, Belgium

San Giovanni Addolorata Hospital; 🇮🇹 Rome, Italy

Hospital de Leon; 🇪🇸 Leon, Spain

University Medical Center Mainz/; 🇩🇪 Mainz, Germany

Institut d'Assistència Sanitària; 🇪🇸 Gerona, Spain

The Royal National Orthopaedic Hospital; 🇬🇧 Stanmore, United Kingdom

O.L. Vrouwziekenhuis; 🇧🇪 Aalst, Belgium

CHIREC du Clinique; 🇧🇪 Bruxelles, Belgium

Katholisches Klinikum Koblenz - Montabaur/; 🇩🇪 Koblenz, Germany

CHC St. Joseph; 🇧🇪 Liege, Belgium