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OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01613144
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
Alphatec Spine, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Osteoporosis Poor Bone Quality 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 Design
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Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 2012
Actual Primary Completion Date : February 12, 2017
Actual Study Completion Date : November 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Efficacy Endpoint: Successful radiographic fusion [ Time Frame: 24 months ]
    Presence of continuous bridging bone across the implant


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Adverse events [ Time Frame: 24 months ]
    Adverse event rates


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613144


Locations
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Belgium
O.L. Vrouwziekenhuis
Aalst, Belgium
CHIREC du Clinique
Bruxelles, Belgium
ULB Hopital Erasme
Bruxelles, Belgium
CHC St. Joseph
Liege, Belgium
Germany
Katholisches Klinikum Koblenz - Montabaur/
Koblenz, Germany
University Medical Center Mainz/
Mainz, Germany
Italy
San Giovanni Addolorata Hospital
Rome, Italy
Spain
Institut d'Assistència Sanitària
Gerona, Spain
Hospital de Leon
Leon, Spain
United Kingdom
The Royal National Orthopaedic Hospital
Stanmore, United Kingdom
Sponsors and Collaborators
Alphatec Spine, Inc.
Investigators
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Study Director: Bita Ghadimi Alphatec Spine, Inc.
More Information
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Responsible Party: Alphatec Spine, Inc.
ClinicalTrials.gov Identifier: NCT01613144    
Other Study ID Numbers: REC-000784
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Alphatec Spine, Inc.:
Osteopenia
Stenosis
Instability
Tumor
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases