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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

September 11, 2012
September 12, 2012
January 2009
July 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01684631 on ClinicalTrials.gov Archive Site
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
Same as current
  • 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.
Same as current
 
Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement
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.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients susceptible to receive a PINNACLE® ULTAMET™ implant

Arthropathy of Hip
Device: Total Hip arthroplasty
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.
Intervention: Device: Total Hip arthroplasty
Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
July 2015
July 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01684631
27062008
No
DePuy International
DePuy International
Not Provided
Principal Investigator: Jean-Marie Toupin, MD Unafiliated
Study Director: Genevieve d'Orsay, MD DePuy
DePuy International
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP