Outcome After Avascular Necrosis of the Femoral Head in Young Patients

Avascular Necrosis of the Femoral Head Clinical Trial

— AVN  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03753282
• Other study ID #: 2018-01264; ch18Saxer3
• Status: Withdrawn
• Start date: January 30, 2019
• Est. completion date: March 5, 2019

Study information

• Verified date: March 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 5, 2019
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Avascular Necrosis of the Femoral Head
• Femur Head Necrosis
• Necrosis
• Osteonecrosis

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arthroplasty-free interval (time until THA)	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
Primary	rate of reoperations after THA	reoperation after THA = time to event data (in the years between 2000-2007)	single time point assessment at baseline
Secondary	Hip disability and Osteoarthritis Outcome Score (HOOS)	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
Secondary	Euroquol 5 Dimensions (EQ-5D-5L)	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