Outcome After Avascular Necrosis of the Femoral Head in Young Patients

NCT03753282 | Withdrawn

• 1 other identifier: 2018-01264; ch18Saxer3
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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.

Conditions

Avascular Necrosis of the Femoral Head

Keywords

Total hip arthroplasty; Total hip replacement

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Hip disability and Osteoarthritis Outcome Score (HOOS)

  single time point assessment at baseline

• Euroquol 5 Dimensions (EQ-5D-5L)

  single time point assessment at baseline

Study Arms (2)

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; Other: questionnaire for course of the disease

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; Other: questionnaire for course of the disease

Interventions

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

Population 1; Population 2

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

Population 1; Population 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• MRI of the hip available from diagnosis at the USB or KSBL Liestal
• Informed Consent

You may not qualify if:

• Insufficient knowledge of project languages (English, German, French)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

MeSH Terms

Conditions

Femur Head Necrosis

Interventions

Surveys and Questionnaires; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Care Surveys; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Health Services Administration

Study Officials

• Franziska Saxer, Dr. med

  Dep. of Orthopedic and Trauma Surgery; University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 26, 2018
• Study Start: January 30, 2019
• Primary Completion: March 5, 2019
• Study Completion: March 5, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03