Incorporation of vitamin E to a polyethylene acetabular cup gives less wear at 10 years compared to cross-linked polyethylene without vitamin E.
ID
Bron
Verkorte titel
Aandoening
Total Hip Arthroplasty, Vitamin E, polyethylene, wear
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Polyethylene wear (mm/y) at 10 years postoperatively.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Incorporation of vitamin E to a polyethylene acetabular cup gives less wear at 10 years compared to cross-linked polyethylene without vitamin E.
Onderzoeksopzet
See above.
Onderzoeksproduct en/of interventie
Both investigated groups will receive a reversed hybrid total hip arthroplasty. Gentamycine cement (Palacos®R+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.
Publiek
Van Swietenplein 1
H.C. Veen, van der
Groningen 9728 NT
The Netherlands
+31 (0)50 5245245
hcvanderveen@hotmail.com
Wetenschappelijk
Van Swietenplein 1
H.C. Veen, van der
Groningen 9728 NT
The Netherlands
+31 (0)50 5245245
hcvanderveen@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with non-inflammatory degenerative joint disease of the hip, scheduled for a primary unilateral total hip arthroplasty;
2. Age < 70 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Secondary osteoarthritis of the hip;
2. (Active) arthritis (eg rheumatic disease);
3. Peripheral neuropathy;
4. History of CVA;
5. Cognitive impairment (eg dementia).
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 | NL2903 |
NTR-old | NTR3049 |
CCMO | NL37132.099.11 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON53149 |