No registrations found.
ID
Source
Brief title
Health condition
hemiarthroplasty
kophalsprothese
cement
cementless
ongecementeerd
femoral neck fracture
mediale collum fractuur
Sponsors and support
-Reinier de Graaf Gasthuis Delft
-Ziekenhuis Rijnstate Arnhem
-Canisius Wilhelmina Ziekenhuis Nijmegen
-Elisabeth Ziekenhuis Tilburg.
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Based on the recent Cochrane analysis no preference can be found for using a non cemented or a cemented hemiarthroplasty. This study has been designed to compare a cemented and a non cemented hemiarthroplasty as a treatment for a displaced femoral neck fracture. The results of this trial will be published as soon as they become available.
Study objective
We hypothesise that not using bone cement in hemiarthroplasty for proximal femoral fractures in elderly patients will at least have comparable functional outcomes and complications with a shorter operation time.
Study design
1. Follow up of 1 year;
2. Measurements at 0,6,12 and 52 weeks.
Intervention
Randomisation to either a cemented hemiarthroplasty Muller (Zimmer) or a non cemented hemiarthroplasty, DB 10 (Biomet).
Department of Orthopaedics
<br>
PO box 5011
P. Pilot
Delft 2600 GA
The Netherlands
Department of Orthopaedics
<br>
PO box 5011
P. Pilot
Delft 2600 GA
The Netherlands
Inclusion criteria
1. Age > 70 years;
2. Displaced femoral neck fracture;
3. ASA I- IV patient.
Exclusion criteria
1. Pathological fracture;
2. Fracture > 7 days old;
3. ASA V patient.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1447 |
| NTR-old | NTR1508 |
| Other | NL19200.098.07 : ABR number |