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OpenTrials
Completed

NCT Number: NCT01684631

Evaluation of Implant Survival in Patients With a Pinnacle Ultamet 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.

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Key information

Conditions

Arthropathy of Hip

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Herbert, Aix-les-Bains, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Total hip arthroplasty

Device

Primary outcomes

  1. 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 outcomes

  1. Harris Hip Score

    Time frame: pre-operative, 1, 2, 3, 5 years

    Measure of hip function using the Harris Hip Score

Other outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

DePuy International

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Sep 13, 2012
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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