Hip Socket Erosion Study (HIPSTER)

Development of Acetabular Erosion After Hemiarthroplasty: an Exploratory Retrospective Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiarthroplasty; Femoral Neck Fractures; Acetabulum; Protrusion

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Lex D. de Jong, PhD; Phone Number: 0031880058275; Email: lddejong@rijnstate.nl
• Study Contact Backup: Name: Matthijs P. Somford, MD, PhD; Phone Number: 003188005; Email: msomford@rijnstate.nl

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6800 WC
      • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Hospital patients who have received hemiarthroplasty after femoral neck fracture

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with acetabular erosion	The proportion of patients after HA who have developed acetabular erosion in the years post-surgery.	Up to 15 years after index surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of patients who have had conversion surgeries	The number (frequency) of patients who have had conversion surgery after the index surgery.	Up to 15 years after index surgery

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: Noordwest Ziekenhuisgroep; Maxima Medical Center; Jeroen Bosch Ziekenhuis; Isala
• Investigators: Principal Investigator: Matthijs P. Somford, MD, PhD, Stichting Rijnstate Ziekenhuis

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: 2023-2224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No