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OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Alphatec Spine, Inc. Identifier:
First received: May 31, 2012
Last updated: January 15, 2016
Last verified: January 2016
This is an Open-label, prospective, randomized, multi-center post-market study.

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)
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

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01613144

O.L. Vrouwziekenhuis
Aalst, Belgium
CHIREC parc Leopold
Bruxelles, Belgium
ULB Hopital Erasme
Bruxelles, Belgium
CHC St. Joseph
Liege, Belgium
San Giovanni Addolorata Hospital
Rome, Italy
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. Identifier: NCT01613144     History of Changes
Other Study ID Numbers: REC-000784
Study First Received: May 31, 2012
Last Updated: January 15, 2016

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs processed this record on August 18, 2017