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

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03753282
• Collaborator: (none)
• Enrollment: 0
• Actual Duration (Months): 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Avascular Necrosis of the Femoral Head	Other: questionnaires for patient reported outcome; Other: questionnaire for course of the disease

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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Outcome After Avascular Necrosis of the Femoral Head in Young Patients - Retrospective Analysis With a Min. 10-year Follow-up
• Actual Study Start Date: Jan 30, 2019
• Actual Primary Completion Date: Mar 5, 2019
• Actual Study Completion Date: Mar 5, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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 Outcome Measures

1. 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

2. 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 Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03753282
• Other Study ID Numbers: 2018-01264; ch18Saxer3
• First Posted: Nov 26, 2018
• Last Update Posted: Mar 29, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: Total hip arthroplasty; Total hip replacement
• Additional relevant MeSH terms: Osteonecrosis; Femur Head Necrosis; Necrosis

Study Results

No Results Posted as of Mar 29, 2019