Outcome After Avascular Necrosis of the Femoral Head in Young Patients

NCT03753282 — Withdrawn, University Hospital, Basel, Switzerland

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

Registry	NCT03753282, acronym AVN
Status	Withdrawn - difficulty enrolling patients, no patient recruited
Study type	Observational
Sponsor	University Hospital, Basel, Switzerland (Other)
Conditions	Avascular Necrosis of the Femoral Head
Interventions	questionnaires for patient reported outcome, questionnaire for course of the disease (Other)
Dates	start 2019-01-30, primary completion 2019-03-05, completion 2019-03-05, first posted 2018-11-26, last updated 2019-03-29

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Population 1		Other: questionnaires for patient reported outcome; Other: 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)
Population 2		Other: questionnaires for patient reported outcome; Other: 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)

questionnaires for patient reported outcome (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 (Other): questionnaires to assess course of the disease: * from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA) * therapeutic interventions

+Outcome measures

Primary outcomes

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)
rate of reoperations after THA [single time point assessment at baseline]: reoperation after THA = time to event data (in the years between 2000-2007)

Secondary outcomes

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.

+Eligibility

Sex: All

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)

+Investigators

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

+Funding

NIH grants: 2018

My Notes

Public

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