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Wear rate of a Highly Cross-Linked polyethylene stabilized with vitamin E in Total Hip Arthroplasty. A Randomized Controlled Trial.


- candidate number7794
- NTR NumberNTR2229
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-feb-2010
- Secondary IDsNL31682.100.10 METC CCMO
- Public TitleWear rate of a Highly Cross-Linked polyethylene stabilized with vitamin E in Total Hip Arthroplasty. A Randomized Controlled Trial.
- Scientific TitleWear rate of a Highly Cross-Linked polyethylene stabilized with vitamin E in Total Hip Arthroplasty. A Randomized Controlled Trial.
- ACRONYMHipVit
- hypothesisThe highly cross-linked polyethylene acetabular liner stabilized with Vitamin E has less wear at two years compared with conventional UHMW polyethylene.
- Healt Condition(s) or Problem(s) studiedTotal Hip Arthroplasty, Vitamin E, Highly cross-linked polyethylene
- Inclusion criteria1. 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.
- Exclusion criteria1. Patients designated for revision surgery;
2. Suffer from sepsis, malignant tumours, severe diabetes mellitus, severe cardiovascular diseases (ASA>II).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2011
- planned closingdate1-mei-2013
- Target number of participants200
- InterventionsTotal 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).
- Primary outcomeThe primary final study point is the polyethylene wear rate at 24 months after total hip arthroplasty.
- Secondary outcome1. Harris Hip Score, reflecting both function and pain The subjective variables are pain activities of daily living. The objective variables are range of motion and hip positioning which give a total of 100 points. ROM includes flexion, extension, abduction, adduction, external rotation and internal rotation measured using a goniometer;
2. Pain level will be determined using a 10-point Visual Analog Scale (VAS), in which 0 implies no pain and 10 implies the worst possible pain;
3. The Short-Form 36 (SF-36), is a validated multi-purpose, short-form health survey with 36 questions, representing eight health domains that are combined into a physical and a mental component scale;
4. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a 24-item questionnaire completed by the patient and focusing on joint pain, stiffness and loss of function related to osteoarthritis of hip;
5. Functional status and activity level will be assessed with the Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH);
6. Complication rates: infection, neurovascular injury, malpositioning of the prosthesis, asceptic loosening of the prosthesis and dislocation.
- TimepointsMeasuring is based on anterior-posterior (AP) radiographs and questionnaires at 3, 12 and 24 months after surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. R. Eshuis
- CONTACT for SCIENTIFIC QUERIESDr. A. Gast, de
- Sponsor/Initiator Diakonessenhuis Zeist, Diakonessenhuis Utrecht, Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Diakonessenhuis Utrecht, Department of Surgery, Diakonessenhuis Zeist, Diakonessenhuis Doorn
- PublicationsN/A
- Brief summaryWear rate of a Highly Cross-Linked polyethylene stabilized with vitamin E in Total Hip Arthroplasty. A Randomized Controlled Trial.
- Main changes (audit trail)
- RECORD26-feb-2010 - 24-jun-2011


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