No registrations found.
ID
Source
Brief title
Health condition
Total Hip Arthroplasty, Vitamin E, polyethylene, wear
Sponsors and support
Intervention
Outcome measures
Primary outcome
Polyethylene wear (mm/y) at 10 years postoperatively.
Secondary outcome
1. 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.
Background summary
N/A
Study objective
Incorporation of vitamin E to a polyethylene acetabular cup gives less wear at 10 years compared to cross-linked polyethylene without vitamin E.
Study design
See above.
Intervention
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.
Van Swietenplein 1
H.C. Veen, van der
Groningen 9728 NT
The Netherlands
+31 (0)50 5245245
hcvanderveen@hotmail.com
Van Swietenplein 1
H.C. Veen, van der
Groningen 9728 NT
The Netherlands
+31 (0)50 5245245
hcvanderveen@hotmail.com
Inclusion criteria
1. Patients with non-inflammatory degenerative joint disease of the hip, scheduled for a primary unilateral total hip arthroplasty;
2. Age < 70 years.
Exclusion criteria
1. Secondary osteoarthritis of the hip;
2. (Active) arthritis (eg rheumatic disease);
3. Peripheral neuropathy;
4. History of CVA;
5. Cognitive impairment (eg dementia).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2903 |
| NTR-old | NTR3049 |
| CCMO | NL37132.099.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON53149 |