Clinical, Radiographic and Laboratory Analysis of Failures of Joint Replacements

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Scott Ball, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01567696
First received: March 28, 2012
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to more fully understand the reason(s) that joint replacement implants fail and to better identify diagnosis and outcome methods both pre-operatively and post-operatively with revision surgery. Analysis of joint replacement failure will include a through analysis of laboratory, radiographic, implant, surgical and demographic data.


Condition
Joint

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Defining the Inflammatory Cytokines in Patients With Adverse Reactions to Metal-on-Metal Hip Replacements

Further study details as provided by University of California, San Diego:

Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

To examine all clinical data in patients with failed total hip and total knee replacements including patient demographics (age, sex, comorbidities, etc.), patient clinical data (history and physical exam and lab findings) and including implant specifications and radiographic findings (for implant type, implant size, implant bearing surface type, position, stability, etc.).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients ≥18 years of age, that present with a failed joint replacement.

Criteria

Inclusion Criteria:

  • ≥18 years of age
  • failed hip or knee replacement
  • willing to sign informed consent

Exclusion Criteria:

  • none
  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: NCT01567696

Contacts
Contact: Scott Ball, MD 858-657-8200 stball@ucsd.edu

Locations
United States, California
UC San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Scott Ball, MD    619-657-8200    stball@ucsd.edu   
Principal Investigator: Scott Ball, MD         
Sub-Investigator: R Scott Meyer, MD         
Sub-Investigator: Anna Kulidjian, MD         
Sub-Investigator: Francis Gonzales, MD         
Sub-Investigator: Dustyn Severns, PA-C, MS         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Scott Ball, MD UCSD
  More Information

No publications provided

Responsible Party: Scott Ball, MD, Assistant Clinical Professor; Chief, Joint Reconstruction, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01567696     History of Changes
Other Study ID Numbers: IIS-000135/11007
Study First Received: March 28, 2012
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
Revision,

ClinicalTrials.gov processed this record on September 16, 2014