Outcome After Avascular Necrosis of the Femoral Head in Young Patients

Withdrawn

• Conditions: Avascular Necrosis of the Femoral Head
• Interventions: Other: questionnaires for patient reported outcome; Other: questionnaire for course of the disease

• Registration Number: NCT03753282
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

1. The course of AVN between Initial diagnosis and total hip replacement (THA) is analysed. The impact of early interventions versus conservative therapy in AVN before THA will be evaluated.

2. The short and long term outcomes of AVN patients undergoing THA with respect to complications, reoperations and quality of life are investigated. Potential risk factors for adverse outcomes will be investigated.

Detailed Description

The study is to describe the course of avascular necrosis (AVN) of the femoral head from initial diagnosis and to collect data on treatment options and the further course in these cases. The duration from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA) will be analysed and the course after joint replacement with potential short- and long-term complications will be evaluated.

The impact of THA after AVN on activities of daily living will be assessed by Euroquol 5 Dimensions (EQ-5D-5L) and Hip disability and Osteoarthritis Outcome Score (HOOS) questionnaires.

Study Timeline

• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-11-23
• Study First Posted: 2018-11-26
• Study Start: 2019-01-30
• Status Verified: 2019-03
• Primary Completion: 2019-03-05
• Study Completion: 2019-03-05
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• MRI of the hip available from diagnosis at the USB or KSBL Liestal
• Informed Consent

Exclusion Criteria

• Insufficient knowledge of project languages (English, German, French)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Population 2	questionnaire for course of the disease	Patients with a THA because of AVN in the years 2000-2007 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease)
Population 2	questionnaires for patient reported outcome	Patients with a THA because of AVN in the years 2000-2007 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease)
Population 1	questionnaires for patient reported outcome	Patients with a first AVN-related contact (initial or confirmed diagnosis) at the Universitätsspital Basel (USB) or Kantonsspital Basel-Liestal (KSBL) in the years between 1999-2006 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease)
Population 1	questionnaire for course of the disease	Patients with a first AVN-related contact (initial or confirmed diagnosis) at the Universitätsspital Basel (USB) or Kantonsspital Basel-Liestal (KSBL) in the years between 1999-2006 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease)

Primary Outcome Measures

Name	Time	Method
rate of reoperations after THA	single time point assessment at baseline	reoperation after THA = time to event data (in the years between 2000-2007)
arthroplasty-free interval (time until THA)	single time point assessment at baseline	time from first diagnosis of AVN to joint replacement = time to event data (in the years between 1999-2006)

Secondary Outcome Measures

Name	Time	Method
Hip disability and Osteoarthritis Outcome Score (HOOS)	single time point assessment at baseline	40 item questionnaire to assess patient-relevant outcomes in five separate subscales (pain, symptoms, activity of daily living, sport and recreation function and hip related quality of life). Scores are: None, Mild, Moderate, Severe, Extreme
Euroquol 5 Dimensions (EQ-5D-5L)	single time point assessment at baseline	Five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.