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Wear analysis of cross-linked versus conventional polyethylene acetabulum cups in cemented primary total hip arthroplasty


- candidate number27356
- NTR NumberNTR6814
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jun-2017
- Secondary IDsNL46774.099.13 
- Public TitleWear analysis of cross-linked versus conventional polyethylene acetabulum cups in cemented primary total hip arthroplasty
- Scientific TitleWear analysis of highly cross-linked versus conventional polyethylene Flanged Anti-Luxation (FAL®) cups in cemented primary total hip arthroplasty: a randomized controlled trial.
- ACRONYMFAL cup trial
- hypothesisIt 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.
- Healt Condition(s) or Problem(s) studiedTotal Hip Arthroplasty, Polyethylene
- Inclusion criteriaPatients 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 criteriaPatients 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-apr-2015
- planned closingdate1-jul-2028
- Target number of participants106
- InterventionsPatients 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.
- Primary outcomeMean annual polyethylene wear rate in millimetres at 5 years postoperatively
- Secondary outcome1. 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
- TimepointsPreoperatively and postoperativey at 6 weeks, 3 months, 1 year, 3 years, 5 years and 10 years
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. B. Dijkstra
- CONTACT for SCIENTIFIC QUERIESDr. W. Zijlstra
- Sponsor/Initiator Medical Centre Leeuwarden, Department of Orthopedic Surgey
- Funding
(Source(s) of Monetary or Material Support)
Link Nederland, Medical Centre Leeuwarden, Department of Orthopedic Surgey
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD6-jun-2017 - 30-nov-2017


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