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.
ID
Bron
Verkorte titel
Aandoening
hemiarthroplasty
kophalsprothese
cement
cementless
ongecementeerd
femoral neck fracture
mediale collum fractuur
Ondersteuning
-Reinier de Graaf Gasthuis Delft
-Ziekenhuis Rijnstate Arnhem
-Canisius Wilhelmina Ziekenhuis Nijmegen
-Elisabeth Ziekenhuis Tilburg.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Duration of surgery is defined as skin-to-skin surgical time, measured in minutes;
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2. Functional outcome is measured by the Time-Up-and Go (TUG) score and the Groningen Activity Restriction Scale (GARS);
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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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
1. Follow up of 1 year;
2. Measurements at 0,6,12 and 52 weeks.
Onderzoeksproduct en/of interventie
Randomisation to either a cemented hemiarthroplasty Muller (Zimmer) or a non cemented hemiarthroplasty, DB 10 (Biomet).
Publiek
Department of Orthopaedics
<br>
PO box 5011
P. Pilot
Delft 2600 GA
The Netherlands
Wetenschappelijk
Department of Orthopaedics
<br>
PO box 5011
P. Pilot
Delft 2600 GA
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age > 70 years;
2. Displaced femoral neck fracture;
3. ASA I- IV patient.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pathological fracture;
2. Fracture > 7 days old;
3. ASA V patient.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1447 |
| NTR-old | NTR1508 |
| Ander register | NL19200.098.07 : ABR number |