Hip Socket Erosion Study

Femoral Neck Fractures Clinical Trial

— HIPSTER  

Official title:

Development of Acetabular Erosion After Hemiarthroplasty: an Exploratory Retrospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06096883
• Other study ID #: 2023-2224
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Rijnstate Hospital
• Contact: Lex D. de Jong, PhD
• Phone: 0031880058275
• Email: lddejong[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: N/A to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Hemiarthroplasty

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (5)

Lead Sponsor	Collaborator
Rijnstate Hospital	Isala, Jeroen Bosch Ziekenhuis, Maxima Medical Center, Noordwest Ziekenhuisgroep

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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