Minimal-Dataset for the Assessment of Surgical outcomes – potential in hip surgery

Conditions: S72.00
M24.05

Registration Number: DRKS00012991

Lead Sponsor: niversitätsspital Basel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 300

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

- 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study examines five independent research questions, which are as follows:<br><br>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.<br>2. The time of reaching a stable level with respect to the outcome selected under point 1 in 75% of patients.<br>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.<br>4. The effect of individual risk factors on the outcome determined under point 1 at the time specified in point 2.<br>5. The effect of individual complications and their classification systems on the outcome determined under point 1 at the time specified under point 2.<br>

Secondary Outcome Measures

Name	Time	Method
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