S72 M24
Conditions
Interventions
Group 1: Patient data becomes the baseline
based on different questionnaires (HRQoL et al.) and two functional tests (30 s chair-stand test and 40 m fast passed walking test) and collected again durin
Sponsors
Universitätsspital Basel
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Femoral neck fracture with indication for partial or total hip replacement - Arthritis of the hip joint with indication for prosthetic joint replacement surgery and - Age =18 years - Written informed consent by the patient or a legal representative (cf. Section 3.4)
Exclusion criteria
Exclusion criteria: - Refusal of standard treatment - Refusal of study participation - Patients not intending to perform follow up visits at the participating hospitals (e.g. if coming from abroad) - Known- or newly diagnosed malignancy - Palliative care situation - Participation in an interventional clinical trial during the last 3 month (e.g. trials on musculoskeletal/rheumatologic disease, drug trials influencing the quality of life etc.) - Foreign language patients, for whom it is unrealistic to obtain the patient reported outcomes in spite of assistance by a study nurse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study examines five independent research questions, which are as follows: 1. The degree of the influence of known factors for the quality of treatment on changes to baseline in the generic scores of EuroQuol5 (EQ-5D) and Health Utility Index Mark 3 (HUI3), the disease-specific Hip Disability and Osteoarthritis Outcome Score (HOOS), and in two functional tests at three different measurement times between 3 and 12 months. 2. The time of reaching a stable level with respect to the outcome selected under point 1 in 75% of patients. 3. The differences between self and foreign determination and the determination of the health-related quality of life regarding the outcomes defined under point 1. 4. The effect of individual risk factors on the outcome determined under point 1 at the time specified in point 2. 5. The effect of individual complications and their classification systems on the outcome determined under point 1 at the time specified under point 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. JUSTIFICATION OF GENERIC INSTRUMENTS AS MEASURE FOR HEATH-RELATED-QUALITY-OF-LIVE (HRQOL).2.CHOICE OF OPTIMAL FOLLOW UP TIMEPOINT. 3. RELIABILITY OF PROXY-BASED ASSESSMENTS 4. IDENTIFICATION OF RELEVANT RISK FACTORS. 5. IMPORTANCE OF COMPLICATIONS AS PART OF A MINIMAL DATA SET | — |
Countries
Switzerland
Contacts
Public ContactMartin Clauss
University Hospital Basel, Dpt. of Orthopedics and Trauma Surgery
Outcome results
None listed