OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Poor Bone Quality
• Intervention / Treatment: Device: OsseoScrew Spinal Fixation System

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 Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • O.L. Vrouwziekenhuis
  • Bruxelles, Belgium
    • ULB Hôpital Erasme
  • Bruxelles, Belgium
    • CHIREC du Clinique
  • Liege, Belgium
    • CHC St. Joseph
• Germany
  • Koblenz, Germany
    • Katholisches Klinikum Koblenz - Montabaur/
  • Mainz, Germany
    • University Medical Center Mainz/
• Italy
  • Rome, Italy
    • San Giovanni Addolorata Hospital
• Spain
  • Gerona, Spain
    • Institut d'Assistència Sanitària
  • Leon, Spain
    • Hospital de Leon
• United Kingdom
  • Stanmore, United Kingdom
    • The Royal National Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

150 skeletally mature study subjects with spinal instability and osteopenia will be enrolled in the study. Subjects will be randomized 1:1 to the OsseoScrew or the control group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OsseoScrew; Test Product: OsseoScrew Spinal Fixation System	Device: OsseoScrew Spinal Fixation System; Surgical intervention
Fenestrated Screw; Control Product: Any commercially available fenestrated screw system augmented with PMMA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alphatec Spine, Inc.
• Investigators: Study Director: Bita Ghadimi, Alphatec Spine, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): February 12, 2017
• Study Completion (ACTUAL): November 8, 2017

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: June 4, 2012
• First Posted (ESTIMATE): June 7, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Stenosis; Tumor; Osteopenia; Instability
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: REC-000784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes