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CompletedNCT01684631Updated Sep 26, 2016

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

An observational study in Arthropathy of Hip, sponsored by DePuy International. Completed at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-26.

Sponsored by DePuy International · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
107
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Arthropathy of Hip

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03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 107 is close to the median of 100 across 216 observational studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

DePuy International is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients susceptible to receive a PINNACLE® ULTAMET™ implant

Inclusion criteria

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

Exclusion criteria

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
107 participants (actual)

Groups and cohorts

  • 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

Interventions

  • DeviceTotal Hip arthroplasty
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What researchers measure

Primary outcomes

  1. Implant Survival Rate

    Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.

    Time frame: up to 5 years

Secondary outcomes

  1. Harris Hip Score

    Measure of hip function using the Harris Hip Score

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

Other outcomes

  1. Cobalt and Chromium serum concentration

    Descriptive analysis of patient serum concentration of Cobalt and Chromium

    Time frame: 3 to 6 Months, 1, 2, 3, 5 years

  2. Adverse Event Frequency

    Descriptive Analysis of Adverse Event Frequency for the duration of the study.

    Time frame: Per-operative, 3 to 6 Months, 1, 2, 3, 5 years

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Study locations

6 sites
  • Clinique Herbert
    Aix-les-Bains, 73100, France
  • Clinique Bonnefon
    Ales, 30104, France
  • Centre Hospitalier Georges Renon
    Niort, 79021, France
  • Clinique Saint Hilaire
    Rouen, 76000, France
  • Clinique Pasteur
    Royan, 17200, France
  • Clinique Mutualiste Saint Etienne
    Saint Etienne, 42013, France
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References and documents

Publications

  • 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. No abstract available. PubMed 5783851 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01684631
Lead sponsor
DePuy International
Responsible party
Sponsor
First posted
Sep 13, 2012
Start date
Jan 2009
Primary completion
Nov 2015
Completion
Dec 2015
Last update
Sep 26, 2016

Study contacts

Jean-Marie Toupin, MD
principal investigator · Clinique Saint Hilaire Rouen, France 76000

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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