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WEAR, BONE DENSITY, FUNCTIONAL OUTCOME AND SURVIVAL IN VITAMIN E INCORPORATED CUPS IN TOTAL HIP ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL.


- candidate number10287
- NTR NumberNTR3049
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-aug-2011
- Secondary IDsNL37132.099.11  CCMO
- Public TitleWEAR, BONE DENSITY, FUNCTIONAL OUTCOME AND SURVIVAL IN VITAMIN E INCORPORATED CUPS IN TOTAL HIP ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL.
- Scientific TitleWEAR, BONE DENSITY, FUNCTIONAL OUTCOME AND SURVIVAL IN VITAMIN E INCORPORATED POLYETHYLENE CUPS IN REVERSED HYBRID TOTAL HIP ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL.
- ACRONYME-VITA
- hypothesisIncorporation of vitamin E to a polyethylene acetabular cup gives less wear at 10 years compared to cross-linked polyethylene without vitamin E.
- Healt Condition(s) or Problem(s) studiedTotal Hip Arthroplasty, Vitamin E, Wear, Polyethylene
- Inclusion criteria1. Patients with non-inflammatory degenerative joint disease of the hip, scheduled for a primary unilateral total hip arthroplasty;
2. Age < 70 years.
- Exclusion criteria1. Secondary osteoarthritis of the hip;
2. (Active) arthritis (eg rheumatic disease);
3. Peripheral neuropathy;
4. History of CVA;
5. Cognitive impairment (eg dementia).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2011
- planned closingdate1-okt-2023
- Target number of participants150
- InterventionsBoth investigated groups will receive a reversed hybrid total hip arthroplasty. Gentamycine cement (PalacosŪR+G, Heraeus) will be used for cup fixation, applying modern cementing techniques including lavage and pressurization. In both groups, the same cementless 28 mm femoral component is used: A proximally plasma sprayed porous coated titanium alloy (Ti6Al4V) stem (Mallory-Head, Biomet) with a cobalt-chromium-molybdenum 28 mm femoral head.
One group will receive a cemented vitamin E stabilized polyethylene acetabular component (E1 Muller cup, Exceed ABT Cemented Cup System, Biomet). The other group will receive a cemented polyethylene acetabular component without the adjunction of vitamin E (ArCom Muller cup, Exceed ABT Cemented Cup System, Biomet).

According to the surgeon’s preference, a posterolateral or anterolateral surgical approach in lateral decubitus position is used. Antibiotic prophylaxis with a first-generation cephalosporin will be given preoperatively and during the first twenty-four hours intravenously.
- Primary outcomePolyethylene wear (mm/y) at 10 years postoperatively.
- Secondary outcome1. Polyethylene wear at 1, 3, 5 and 7 years postoperatively;
2. Relative decrease/increase in acetabular bone mineral density (BMD) at 1 and 2 years postoperatively;
3. Acetabular and proximal femoral osteolytic changes at 1, 3, 5, 7 and 10 years postoperatively;
4. Patient-reported functional outcome, health related quality of life and physical activity (HOOS) and physician-reported functional outcome (Harris Hip Score) at 6 weeks and 1, 3, 5, 7 and 10 years postoperatively;
5. Physical activity behaviour (SQUASH) at 1, 3, 5 and 10 years postoperatively;
6. Survival (number of revisions) determined at 5 and 10 years postoperatively.
- TimepointsSee above.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. H.C. Veen, van der
- CONTACT for SCIENTIFIC QUERIESDr. J.J.A.M. Raay, van
- Sponsor/Initiator Martini Hospital, Department of Orthopaedic Surgery,, University Medical Center Groningen (UMCG), Department Orthopaedic Surgery
- Funding
(Source(s) of Monetary or Material Support)
Martini Hospital, Department of Orthopaedic Surgery, Biomet Nederland, Dordrecht
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD29-aug-2011 - 12-sep-2011


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