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Evaluation of Predictive Factors for Ruptures of Meije Duo â„¢ Size 1 and 2 Femoral Stems in Hip Replacement Surgery

NCT04262713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2023-03-23

No results posted yet for this study

Summary

A normative development concerning the mechanical resistance tests of the the femoral stems led to contraindicate, in September 2014, to implant Meije Duo â„¢ femoral stems size 1 or 2 in patients weighing more than 60 kg due to an assumed risk of femoral stem breakage.

This contraindication is based on standardized mechanical tests which may have not taken into account the changes in patient weight that may occur after the intervention.

To date, investigators have not been aware of any Meije Duo â„¢ size 1/2 brakeage in our patients implanted with this type of prosthesis regardless of their weights before 2014. However, it is possible that some of them have had a prostheses failure and consulted another hospital. In the absence of a clinical study on this problem, investigators decided to set up a health care assessment study collecting retrospective and prospective information from our patients.

Conditions

  • Hip Arthropathy Associated With Other Conditions

Interventions

OTHER

Radiographs

Radiographs of the implanted hip with Meije duo size1 or 2 are performed in eligible patients ( Weigh\>60, Long neck stem, Varus; DEVANE score ≥ 4)

Sponsors & Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    lead OTHER

Principal Investigators

  • Simon MARMOR, MD · Groupe Hospitalier Diaconesses Croix Saint-Simon

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-23
Primary Completion
2021-07-12
Completion
2022-04-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262713 on ClinicalTrials.gov