The highly cross-linked polyethylene acetabular liner stabilized with Vitamin E has less wear at two years compared with conventional UHMW polyethylene.
ID
Bron
Verkorte titel
Aandoening
highly cross-linked polyethylene
vitamin E
wear rate
Total Hip Arthroplasty
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary final study point is the polyethylene wear rate at 24 months after total hip arthroplasty.
Achtergrond van het onderzoek
Wear rate of a Highly Cross-Linked polyethylene stabilized with vitamin E in Total Hip Arthroplasty. A Randomized Controlled Trial.
Doel van het onderzoek
The highly cross-linked polyethylene acetabular liner stabilized with Vitamin E has less wear at two years compared with conventional UHMW polyethylene.
Onderzoeksopzet
Measuring is based on anterior-posterior (AP) radiographs and questionnaires at 3, 12 and 24 months after surgery.
Onderzoeksproduct en/of interventie
Total Hip Arthroplasty will be performed using the RM cementless monoblock pressfit cup (Mathys AG Bettlach) or the RM cementless monoblock pressfitt Vitamys cup (Mathys AG Bettlach). Critical aspects of the surgical procedure will be standardized.
RM Pressfit: RM cementless monoblock pressfit cup is a standard implant.
Structure: Elliptical design and a slight polar flattening.
Polyethylene: UHMW- PE.
Coating material: Pure titanium particles (TiCP).
RM pressfitt Vitamys: RM cementless monoblock pressfit cup stabilized with Vitamin E.
The Vitamys cup is a polyethylene from the same raw material as UHMWPE which has been highly cross linked and additionally endowed with 0.1% of vitamin E, an antioxidant also called tocopherol. The average content of Vitamin E in a Vitamys cup is around 50 mg (max daily amount 400mg) The ingredients are homogeneously mixed, sintered under pressure, and highly cross-linked by an irradiation dose of 100kGy.
Structure: Elliptical design and a slight polar flattening.
Polyethylene: UHMW- PE added with natural anti-oxidant, vitamin E.
Coating material: Pure titanium particles (TiCP).
Publiek
R. Eshuis
Zeist 3707 HL
The Netherlands
+31 (0)30 6989757
Wetenschappelijk
R. Eshuis
Zeist 3707 HL
The Netherlands
+31 (0)30 6989757
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients scheduled for a total hip arthroplasty;
2. Patients diagnosed for coxarthrosis, dysplastic coxarthrosis, rheumatoid arthritis , necrosis of the head of the femur or posttraumatic coxarthrosis;
3. Patients between 20 and 75 years old at the time of inclusion.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients designated for revision surgery;
2. Suffer from sepsis, malignant tumours, severe diabetes mellitus, severe cardiovascular diseases (ASA>II).
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 | NL2112 |
| NTR-old | NTR2229 |
| CCMO | NL31682.100.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34827 |