hemiarthroplasty kophalsprothese cement cementless ongecementeerd femoral neck fracture mediale collum fractuur
Conditions
Interventions
Randomisation to either a cemented hemiarthroplasty Muller (Zimmer) or a non cemented hemiarthroplasty, DB 10 (Biomet).
Sponsors
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.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 70 years; 2. Displaced femoral neck fracture; 3. ASA I- IV patient.
Exclusion criteria
Exclusion criteria: 1. Pathological fracture; 2. Fracture > 7 days old; 3. ASA V patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Duration of surgery is defined as skin-to-skin surgical time, measured in minutes; 2. Functional outcome is measured by the Time-Up-and Go (TUG) score and the Groningen Activity Restriction Scale (GARS); 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
| Measure | Time frame |
|---|---|
| 1.Living situation at final follow up, measured in percentage of pre-fracture situation; 2. Self reported health-related quality of life, measured by the SF 12; 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. | — |
Contacts
Public ContactP. Pilot
Reinier de Graaf Gasthuis Delft Department of Orthopaedics PO box 5011
Outcome results
None listed