HIPSTER: Hip Socket Erosion Study

Sponsor
Rijnstate Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06096883
Collaborator
Isala (Other), Jeroen Bosch Ziekenhuis (Other), Maxima Medical Center (Other), Noordwest Ziekenhuisgroep (Other)
500
1
13
38.4

Study Details

Study Description

Brief Summary

The aim of this exploratory retrospective study is to gain a better understanding about the occurrence of acetabular erosion in patients after after hip hemiarthroplasty. The main objectives are i) to summarise a selection of basic patient characteristics of all patients of ≤ 75 years of age with a femoral neck fracture who have received either HA or THA, ii) to explore the proportion of patients after HA who developed acetabular erosion in the first years post-surgery and iii) to explore the proportion of patients after HA for whom acetabular erosion was the main reason for conversion surgery from HA to THA. A secondary objective is to assess the observer reliability of, and explore the association between, the Baker classification grading and Köhler line measurements.

All participants approached for participation in the main phase of the study will be asked to give their written informed consent to use their patient data. Patients who are willing to participate will also be asked to complete a short paper survey to collect data that is not available from their health records.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Some orthopaedic surgeons believe that relatively 'young' older patients (aged ≤ 75 years) who have sustained a femoral neck fracture should be treated with hemiarthroplasty (HA) instead of total hip arthroplasty (THA). The rationale behind this belief is that THA is more time consuming, has greater associated surgical morbidity and may increase the risk of hip dislocation and subsequent revision surgery. On the other hand, HA is believed to accelerate acetabular erosion (i.e. wear) over time, which may ultimately lead to the need for conversion surgery from HA to THA. Due to a lack of research in this area, it is unclear how often the development of acetabular erosion in patients after HA actually occurs. This makes it difficult for orthopaedic surgeons to make an informed choice between HA or THA surgery for this patient group.

    This is an exploratory retrospective study using existing electronic patient data of patients adhering to the inclusion criteria of the study, i.e. patients of ≤ 75 years of age who have had HA after a femoral neck fracture.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Development of Acetabular Erosion After Hemiarthroplasty: an Exploratory Retrospective Study
    Anticipated Study Start Date :
    Dec 1, 2023
    Anticipated Primary Completion Date :
    May 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of patients with acetabular erosion [Up to 15 years after index surgery]

      The proportion of patients after HA who have developed acetabular erosion in the years post-surgery.

    Secondary Outcome Measures

    1. The frequency of patients who have had conversion surgeries [Up to 15 years after index surgery]

      The number (frequency) of patients who have had conversion surgery after the index surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 76 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • having had a displaced femoral neck fracture that was subsequently treated with hemiarthroplasty

    • aged < 75 years at the time of surgery

    • have at least two post-operative radiographs (with at least six weeks between them) available for acetabular erosion measurements.

    Exclusion Criteria:
    • patients diagnosed with rheumatoid arthritis, osteoporosis, hip dysplasia or a previous hip fracture of the ipsilateral hip.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rijnstate Hospital Arnhem Gelderland Netherlands 6800 WC

    Sponsors and Collaborators

    • Rijnstate Hospital
    • Isala
    • Jeroen Bosch Ziekenhuis
    • Maxima Medical Center
    • Noordwest Ziekenhuisgroep

    Investigators

    • Principal Investigator: Matthijs P. Somford, MD, PhD, Stichting Rijnstate Ziekenhuis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rijnstate Hospital
    ClinicalTrials.gov Identifier:
    NCT06096883
    Other Study ID Numbers:
    • 2023-2224
    First Posted:
    Oct 24, 2023
    Last Update Posted:
    Oct 24, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 24, 2023