Outcome After Avascular Necrosis of the Femoral Head in Young Patients (AVN)

March 27, 2019 updated by: University Hospital, Basel, Switzerland

Outcome After Avascular Necrosis of the Femoral Head in Young Patients - Retrospective Analysis With a Min. 10-year Follow-up

  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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Population 1: Patients with a first AVN-related contact (initial or confirmed diagnosis) at the USB or KSBL Liestal in the years between 1999-2006.

Population 2: Patients with a THA because of AVN at the USB or KSBL Liestal in the years 2000-2007.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Population 1
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)
Other: questionnaires for patient reported outcome

questionnaires with respect to outcomes:

  • Reoperations
  • Short term complications
  • Long term complications
  • EQ-5D (current)
  • HOOS (current)
  • disease related change of occupation
  • use of walking aids
  • comorbidities
  • medication
Other: questionnaire for course of the disease

questionnaires to assess course of the disease:

  • from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA)
  • therapeutic interventions
Population 2
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)
Other: questionnaires for patient reported outcome

questionnaires with respect to outcomes:

  • Reoperations
  • Short term complications
  • Long term complications
  • EQ-5D (current)
  • HOOS (current)
  • disease related change of occupation
  • use of walking aids
  • comorbidities
  • medication
Other: questionnaire for course of the disease

questionnaires to assess course of the disease:

  • from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA)
  • therapeutic interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arthroplasty-free interval (time until THA)
Time Frame: 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)
single time point assessment at baseline
rate of reoperations after THA
Time Frame: single time point assessment at baseline
reoperation after THA = time to event data (in the years between 2000-2007)
single time point assessment at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: 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
single time point assessment at baseline
Euroquol 5 Dimensions (EQ-5D-5L)
Time Frame: 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.
single time point assessment at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Franziska Saxer, Dr. med, Dep. of Orthopedic and Trauma Surgery; University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2019

Primary Completion (Actual)

March 5, 2019

Study Completion (Actual)

March 5, 2019

Study Registration Dates

First Submitted

November 23, 2018

First Submitted That Met QC Criteria

November 23, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01264; ch18Saxer3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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