OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Alphatec Spine, Inc.
Sponsor:
Information provided by (Responsible Party):
Alphatec Spine, Inc.
ClinicalTrials.gov Identifier:
NCT01613144
First received: May 31, 2012
Last updated: August 4, 2014
Last verified: August 2014
  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.:

Secondary Outcome Measures:
  • Fusion [ Time Frame: 24 month ] [ Designated as safety issue: No ]

    Successful fusion at 24 month post treatment as determined by:

    • Presence of bridging bone
    • Angular motion < 3 deg
    • Translation motion < 2mm

  • Oswestry Disability Index [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • VAS back and leg pain [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01613144

Contacts
Contact: Bita P Ghadimi Bghadimi@alphatecspine.com

Locations
Belgium
O.L. Vrouwziekenhuis Recruiting
Aalst, Belgium
CHIREC parc Leopold Recruiting
Bruxelles, Belgium
ULB Hopital Erasme Recruiting
Bruxelles, Belgium
CHC St. Joseph Recruiting
Liege, Belgium
Italy
San Giovanni Addolorata Hospital Recruiting
Rome, Italy
Spain
Santa Caterina de Salt Hospital Recruiting
Gerona, Spain
Hospital de Leon Recruiting
Leon, Spain
United Kingdom
The Royal National Orthopaedic Hospital Recruiting
Stanmore, United Kingdom
Sponsors and Collaborators
Alphatec Spine, Inc.
  More Information

No publications provided

Responsible Party: Alphatec Spine, Inc.
ClinicalTrials.gov Identifier: NCT01613144     History of Changes
Other Study ID Numbers: REC-000784
Study First Received: May 31, 2012
Last Updated: August 4, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 19, 2014