• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

  • Print
  • Share
  • E-mail
-
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Metal ion levels


Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
General
522 Number / Requirement Number PS110038 / PSS001
Current Plan Approved 09/22/2013
Study Name Metal ion levels
Root Document Number K080991  K003523  K073413  K070359  K082239  K040627  K093646  K083642  K002883  K023786  K062426  K090998  K073570  K070554  K042992  K061221  K082585 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description "Metal ions and ALTR assessed in cross-sectional multi-center manner. It is anticipated that most subjects will only require one visit; subjects that have an ALTR or possible ALTR diagnosed will be followed for one year or until revision, whichever occurs first.

The primary objective of this clinical evaluation is to estimate chromium and cobalt blood ion levels (serum and whole blood) in the patient population from pre-operatively through 8 years post-operatively. Means for each year, pre-op through 8 years (5 years for the ASR) will be summarized with summary statistics and 95% confidence intervals.

Null Hypothesis Ho: The ion level means at pre-op and each year 1 through 8 years (ASR: 2 through 6 years) post-operatively are all identical

Alternative Hypothesis Ha: The ion level means at pre-op and each respective post-operative time period in the analysis are not all identical"

Study Population Description Patients who received Pinnacle and ASR total hips

hips
Sample Size Pinnacle arm: 9 sites, 250 patients; ASR Arm 6 sites, 150 patients
Data Collection Cobalt and chromium ions, Adverse Local Tissue Reactions (ALTR), clinical (incl. Harris hip score), radiographic, MARS MRI
Follow-up Visits and Length of Follow-up None for most patients; up to 1 year of follow-up for ALTR patients
Final Study Results
Interim Safety Information Study still underway


Metal ion levels Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/28/2013 04/03/2013 On Time
1 year report 10/02/2013 10/02/2013 On Time
2 year report 11/01/2014 10/29/2014 On Time
3 year report 10/01/2015    
4 year report 09/30/2016    
Final Report 11/28/2017    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
-
-