Cemented versus non-cemented hemiarthroplasty of the hip as a treatment for a displaced femoral neck fracture; a multi center randomised trial.
Recruiting
- Conditions
- hemiarthroplastykophalsprothesecementcementlessongecementeerdfemoral neck fracturemediale collum fractuur
- Registration Number
- NL-OMON22861
- Lead Sponsor
- The study will be conducted at the Orthopaedic Departments of: -Reinier de Graaf Gasthuis Delft-Ziekenhuis Rijnstate Arnhem -Canisius Wilhelmina Ziekenhuis Nijmegen -Elisabeth Ziekenhuis Tilburg.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Age > 70 years;
2. Displaced femoral neck fracture;
Exclusion Criteria
1. Pathological fracture;
2. Fracture > 7 days old;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Duration of surgery is defined as skin-to-skin surgical time, measured in minutes;<br><br /><br>2. Functional outcome is measured by the Time-Up-and Go (TUG) score and the Groningen Activity Restriction Scale (GARS);<br><br /><br>3. Postoperative mid thigh pain is measured by a 4 -point ordinal scale (non/mild/ moderate/ severe) score. Mid thigh pain is defined as pain explicit in the front and mid part of the femur.
- Secondary Outcome Measures
Name Time Method 1.Living situation at final follow up, measured in percentage of pre-fracture situation;<br /><br>2. Self reported health-related quality of life, measured by the SF 12;<br /><br>3. Standard radiological evaluation of hemiarthroplasty and cement positioning and adequate size of the hemiarthroplasty measured on plain AP and axial X-rays of the operated hip. Adequate AP positioning is defined as less than 10 degrees varus or valgus. Adequate axial positioning is defined as 0 to 15 degrees anteversion.<br>