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OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)

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ClinicalTrials.gov Identifier: NCT01613144
Recruitment Status : Unknown
Verified January 2016 by Alphatec Spine, Inc..
Recruitment status was:  Active, not recruiting
First Posted : June 7, 2012
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alphatec Spine, Inc.

Brief Summary:
This is an Open-label, prospective, randomized, multi-center post-market study.

Condition or disease
Osteoporosis Poor Bone Quality

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

Study Type : Observational
Actual Enrollment : 90 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
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort
OsseoScrew
Fenestrated Screw



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


Information from the National Library of Medicine

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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)

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.

Responsible Party: Alphatec Spine, Inc.
ClinicalTrials.gov Identifier: NCT01613144     History of Changes
Other Study ID Numbers: REC-000784
First Posted: June 7, 2012    Key Record Dates
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