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Outcome After Avascular Necrosis of the Femoral Head in Young Patients

NCT ID: NCT03753282

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-30

Study Completion Date

2019-03-05

Brief Summary

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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

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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.

Conditions

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Avascular Necrosis of the Femoral Head

Keywords

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Total hip arthroplasty Total hip replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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)

questionnaires for patient reported outcome

Intervention Type OTHER

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

questionnaire for course of the disease

Intervention Type OTHER

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)

questionnaires for patient reported outcome

Intervention Type OTHER

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

questionnaire for course of the disease

Intervention Type OTHER

questionnaires to assess course of the disease:

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franziska Saxer, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Dep. of Orthopedic and Trauma Surgery; University Hospital Basel

Countries

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Switzerland

Other Identifiers

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2018-01264; ch18Saxer3

Identifier Type: -

Identifier Source: org_study_id