It is hypothesized that at 5 year postoperatively, mean annual wear rate in millimetres of the cross-linked polyethylene FAL cups is significantly less compared to the conventional polyethylene FAL cups.
ID
Bron
Verkorte titel
Aandoening
Total hip arthroplasty
Wear
Cross-linked
Polyethylene
Ondersteuning
Link Nederland B.V., Schiedam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Mean annual polyethylene wear rate in millimetres at 5 years postoperatively
Doel van het onderzoek
It is hypothesized that at 5 year postoperatively, mean annual wear rate in millimetres of the cross-linked polyethylene FAL cups is significantly less compared to the conventional polyethylene FAL cups.
Onderzoeksopzet
Preoperatively and postoperativey at 6 weeks, 3 months, 1 year, 3 years, 5 years and 10 years
Onderzoeksproduct en/of interventie
Patients will receive a crosslinked polyethylene FAL cup® (Link) or a conventional polyethylene FAL cup. The femoral stem will be the SP II® (Link). All surgeons will peform a posterolateral surgical approach. All patients will be treated postoperatively following a standardized protocol.
Publiek
B. Dijkstra
Henri Dunantweg 2
Leeuwarden 8934 AD
The Netherlands
+31 (0)50-2867666
Wetenschappelijk
B. Dijkstra
Henri Dunantweg 2
Leeuwarden 8934 AD
The Netherlands
+31 (0)50-2867666
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients with
1. age 65- 80 years
2. symptomatic coxartrosis and scheduled for a cemented total hip replacement
3. physical and mentall ability to come for the postoperative follow-up visits
4. written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients with:
1. standard contraindications for total hip replacement, such as infection and severe pulmonary, cardiovascular or metabolic comorbidity
2. neurlogical disorders that affect walking
3. an inability to fill in the questionnaires due to mental or cognitive impairments
4. insufficient understanding of the Dutch language
5. a Body Mass Index > 40
6. an abnormal hip joint anatomy not suitable for the use of the FAL cup and SPII stem
7. an amputation of the lower extremity
8. malignancy receiving anticancer therapy
9. participation in another trial that might interfere with this study
10. an alcolhol or drug dependency
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6597 |
| NTR-old | NTR6814 |
| CCMO | NL46774.099.13 |
| OMON | NL-OMON40132 |