THA: Study of Radiographic Changes and Their Clinical Implications at 2 Years of Implantation of Shortened Uncemented Femoral Stems in Total Hip Arthroplasty

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05666284
Collaborator
(none)
204
1
12
17

Study Details

Study Description

Brief Summary

The hip prosthesis market is constantly growing with the number of prostheses reaching 949,000 in 2019. Along with this, there is also an increase in interest in short stems also called shortened stems. Thus on Pubmed, in 5 years, 171 publications have been listed.

Thus, it seems interesting to study and analyze the performance of the shortened stem used in the Department of Orthopedic Surgery and Traumatology of the University Hospitals of Strasbourg and to compare them with the results of the literature.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The objective of this study is to observe the appearance of shortened stem radiological abnormalities at least 2 years postoperatively.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    204 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Study of Radiographic Changes and Their Clinical Implications at 2 Years of Implantation of Shortened Uncemented Femoral Stems in Total Hip Arthroplasty
    Actual Study Start Date :
    Oct 11, 2022
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 11, 2023

    Outcome Measures

    Primary Outcome Measures

    1. To observe the appearance of shortened stem radiological abnormalities at least 2 years postoperatively. [2 years postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion criteria:
    • Male or female (age ≥18 years old)

    • Subject operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head

    • Subject who received a THA between January 2015 and December 2019

    • Subject who received an uncemented shortened SCC or SCLA femoral stem

    • Radiological data available: pre-operative, immediate post-operative and post-operative at a minimum of 2 years (≥24 months)

    • Subject not objecting to the reuse of their data for scientific research purposes.

    Exclusion criteria:
    • Subject having expressed its opposition to the reuse of its data for scientific research purposes.

    • Patient operated for inflammatory pathology or major dysplasia, recovery

    • Associated fractures or sequelae of fractures

    • Patient having presented intraoperative or early complications such as infections, intraoperative fracture, dislocation of the hip following the installation of the THA

    • Revision of hip arthroplasty during the study follow-up period for a cause not studied in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Chirurgie Orthopédique et de Traumatologie du Membre Inférieur - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05666284
    Other Study ID Numbers:
    • 8720
    First Posted:
    Dec 27, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 27, 2022