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Trials / Enrolling By Invitation

Enrolling By InvitationNCT06096883

Hip Socket Erosion Study

Development of Acetabular Erosion After Hemiarthroplasty: an Exploratory Retrospective Study

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
500 (estimated)
Sponsor
Rijnstate Hospital · Academic / Other
Sex
All
Age
76 Years
Healthy volunteers

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.

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.

Conditions

Timeline

Start date
2024-06-19
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2023-10-24
Last updated
2025-08-05

Locations

5 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT06096883. Inclusion in this directory is not an endorsement.