Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor

July 23, 2023 updated by: Olivier ROCHE, Central Hospital, Nancy, France

Retrospective, single-centre study. Review of patients aged 85 and over who underwent total hip replacement between June 2015 and February 2022.

This is a femoral stem survival study with calculation of the complication rate in this population.

The study does not focus on total hip replacements in the context of trauma. The secondary endpoint was the search for complication risk factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Centre Chirurgical Emile Gallé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Any people of 85 years of more who received total hip arthroplasty with uncemented stem fully hydroxyapatitis coated

Description

Inclusion Criteria:

  • receive total hip arthroplasty with uncemented stem fully hydroxyapatites coated

Exclusion Criteria:

  • trauma context
  • less than 3 month follow up
  • Any surgery of the hip as medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem
Procedure: Total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of complication
Time Frame: minimum of 3 months follow up
survival study, any complications
minimum of 3 months follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
risk factor of complications
Time Frame: minimum of 3 months follow up
minimum of 3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022PI032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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