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OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01613144
First Posted: June 7, 2012
Last Update Posted: January 18, 2016
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.
Information provided by (Responsible Party):
Alphatec Spine, Inc.
  Purpose
This is an Open-label, prospective, randomized, multi-center post-market study.

Condition
Osteoporosis Poor Bone Quality

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alphatec Spine, Inc.:

Primary Outcome Measures:
  • Compare complication rates [ Time Frame: Record adverse events until the 2 year time point ]

Enrollment: 90
Study Start Date: May 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
OsseoScrew
Fenestrated Screw

Detailed Description:
To collect clinical evidence of safety and efficacy of the OsseoScrew Spinal Fixation System versus fenestrated pedicle screws augmented with polymethylmethacrylate (PMMA) in patients with Osteoporosis or Poor Bone Quality
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Belgium
O.L. Vrouwziekenhuis
Aalst, Belgium
CHIREC parc Leopold
Bruxelles, Belgium
ULB Hopital Erasme
Bruxelles, Belgium
CHC St. Joseph
Liege, Belgium
Italy
San Giovanni Addolorata Hospital
Rome, Italy
Spain
Santa Caterina de Salt Hospital
Gerona, Spain
Hospital de Leon
Leon, Spain
United Kingdom
The Royal National Orthopaedic Hospital
Stanmore, United Kingdom
Sponsors and Collaborators
Alphatec Spine, Inc.
  More Information

Responsible Party: Alphatec Spine, Inc.
ClinicalTrials.gov Identifier: NCT01613144     History of Changes
Other Study ID Numbers: REC-000784
First Submitted: May 31, 2012
First Posted: June 7, 2012
Last Update Posted: January 18, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs