OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

Osteoporosis Clinical Trial

— EVOLVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613144
• Other study ID #: REC-000784
• Status: Completed
• Start date: May 2012
• Est. completion date: November 8, 2017

Study information

• Verified date: February 2022
• Source: Alphatec Spine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 8, 2017
• Est. primary completion date: February 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoporosis
• Poor Bone Quality

Intervention

Device:
• OsseoScrew Spinal Fixation System
Surgical intervention

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Alphatec Spine, Inc.

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Efficacy Endpoint: Successful radiographic fusion	Presence of continuous bridging bone across the implant	24 months
Secondary	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
Secondary	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
Secondary	Adverse events	Adverse event rates	24 months