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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01684631
First received: September 11, 2012
Last updated: September 12, 2012
Last verified: September 2012
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Descriptive Analysis of Adverse Event Frequency for the duration of the study.


Estimated Enrollment: 110
Study Start Date: January 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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 Unafiliated
Study Director: Genevieve d'Orsay, MD DePuy
  More Information

Publications:
Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT01684631     History of Changes
Other Study ID Numbers: 27062008
Study First Received: September 11, 2012
Last Updated: September 12, 2012
Health Authority: France: Ministère de l'Enseignement supérieur et de la Recherche

ClinicalTrials.gov processed this record on September 18, 2014