No registrations found.
ID
Source
Brief title
Health condition
Total hip arthroplasty
Wear
Cross-linked
Polyethylene
Sponsors and support
Link Nederland B.V., Schiedam
Intervention
Outcome measures
Primary outcome
Mean annual polyethylene wear rate in millimetres at 5 years postoperatively
Secondary outcome
1. Mean annual polyethylene wear rate in millimetres at 1, 3 and 10 years postoperatively
2. Mean scores on patient reported outcomes measures (NRS pain, HOOS-PS, OHS, EQ-5D and SQUASH) at 1, 3, 5 and 10 years postoperatively
3. Number of peri-prosthetic lucencies in the 3 zones according DeLee and Charnley at 5 and 10 years postoperatively
4. Number of revisions at 5 and 10 years postoperatively
5. Mean total intramural costs at 5 and 10 years postoperatively
Study objective
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.
Study design
Preoperatively and postoperativey at 6 weeks, 3 months, 1 year, 3 years, 5 years and 10 years
Intervention
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.
B. Dijkstra
Henri Dunantweg 2
Leeuwarden 8934 AD
The Netherlands
+31 (0)50-2867666
B. Dijkstra
Henri Dunantweg 2
Leeuwarden 8934 AD
The Netherlands
+31 (0)50-2867666
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6597 |
| NTR-old | NTR6814 |
| CCMO | NL46774.099.13 |
| OMON | NL-OMON40132 |