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Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01684631
First Posted: September 13, 2012
Last Update Posted: September 26, 2016
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.
Information provided by (Responsible Party):
DePuy International
  Purpose
The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.

Condition Intervention
Arthropathy of Hip Device: Total Hip arthroplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Implant Survival Rate [ Time Frame: up to 5 years ]
    Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.


Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: pre-operative, 1, 2, 3, 5 years ]
    Measure of hip function using the Harris Hip Score


Other Outcome Measures:
  • Cobalt and Chromium serum concentration [ Time Frame: 3 to 6 Months, 1, 2, 3, 5 years ]
    Descriptive analysis of patient serum concentration of Cobalt and Chromium

  • Adverse Event Frequency [ Time Frame: Per-operative, 3 to 6 Months, 1, 2, 3, 5 years ]
    Descriptive Analysis of Adverse Event Frequency for the duration of the study.


Enrollment: 107
Study Start Date: January 2009
Study Completion Date: December 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hip arthroplasty
Patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture.
Device: Total Hip arthroplasty

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients susceptible to receive a PINNACLE® ULTAMET™ implant
Criteria

Inclusion Criteria:

  • Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice

Exclusion Criteria:

  • Patient refusal to participate to the data collection
  • Pregnant woman
  • Patients age is less than 18 years old
  • The planned intervention is a revision of a previous intervention on the studied hip joint
  • Previous metal implant, except for pure titanium or titanium alloys
  • Exposure to cobalt and chromium that could influence serum metal ions levels
  • Planned bilateral intervention
  • Patient residing outside France
  • Patient not implanted with a Pinnacle(R) ULTAMET(TM)
  Contacts and Locations
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): NCT01684631


Locations
France
Clinique Herbert
Aix-les-Bains, France, 73100
Clinique Bonnefon
Ales, France, 30104
Centre Hospitalier Georges Renon
Niort, France, 79021
Clinique Saint Hilaire
Rouen, France, 76000
Clinique Pasteur
Royan, France, 17200
Clinique Mutualiste Saint Etienne
Saint Etienne, France, 42013
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Jean-Marie Toupin, MD Clinique Saint Hilaire Rouen, France 76000
  More Information

Publications:
Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT01684631     History of Changes
Other Study ID Numbers: 27062008
First Submitted: September 11, 2012
First Posted: September 13, 2012
Last Update Posted: September 26, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases