Hip Socket Erosion Study

NCT06096883 | Enrolling By Invitation

• 1 other identifier: 2023-2224
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 5

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.

Conditions

Femoral Neck Fractures; Hemiarthroplasty; Acetabulum; Protrusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The frequency of patients who have had conversion surgeries

  Up to 15 years after index surgery

Eligibility Criteria

• Age: Up to 76 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital patients who have received hemiarthroplasty after femoral neck fracture

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (5)

Rijnstate Hospital

Arnhem, Gelderland, 6800 WC, Netherlands

Location

Jeroen Bosch Hospital, Department of Orthopedics

's-Hertogenbosch, Netherlands

Location

Northwest Clinics, Centre for Orthopaedic Research Alkmaar (CORAL) and Department of Orthopaedic Surgery

Alkmaar, Netherlands

Location

Máxima Medical Center, Department of Orthopaedic Surgery

Eindhoven, Netherlands

Location

Isala Hospital, Department of Orthopaedics

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Matthijs P. Somford, MD, PhD

  Stichting Rijnstate Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: June 19, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

NL (5)