Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Warwick Metal On Metal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02262468
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
Stephen Young, South Warwickshire NHS Foundation Trust

Tracking Information
First Submitted Date October 7, 2014
First Posted Date October 13, 2014
Last Update Posted Date October 13, 2014
Study Start Date April 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 10, 2014)
Oxford hip score [ Time Frame: 6 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Warwick Metal On Metal Study
Official Title Review of 750 36mm MOM Hip Replacements ( Pinnacle/Corail) With up to 6 Year Follow up
Brief Summary assess results of metal on metal hip replacements carried out at warwick hospital
Detailed Description Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of this series.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with 36mm metal on metal hips
Condition Metal Hip Replacement
Intervention Radiation: x ray
Study Groups/Cohorts MOM total hip replacements
all patients with MOM 36mm hip replacements
Intervention: Radiation: x ray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 10, 2014)
750
Original Actual Enrollment Same as current
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients with 36mm metal on metal hips

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02262468
Other Study ID Numbers IIS2012012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stephen Young, South Warwickshire NHS Foundation Trust
Study Sponsor South Warwickshire NHS Foundation Trust
Collaborators DePuy International
Investigators Not Provided
PRS Account South Warwickshire NHS Foundation Trust
Verification Date October 2014