A comparison of the wear rate of two polyethylene acetabular liners.;A Randomized Controlled Trial

Completed

Conditions: 10005944
coxarthosis
hip arthrosis
10023213

Registration Number: NL-OMON34388

Lead Sponsor: Diakonessenhuis Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Patients scheduled for a total hip arthroplasty. Inclusion criterion, patients diagnosed for coxarthrosis, dysplastic coxarthrosis, rheumatoid arthritis, necrosis of the head of the femur or posttraumatic coxarthrosis. Patients between 55 and 75 years old at the time of inclusion. Patient radiographic templated for a 32mm femoral head prosthesis

Exclusion Criteria

Exclusion criteria; patients designated for revision surgery, suffer from sepsis, malignant tumours, severe diabetes mellitus (ASA >II), severe cardiovascular diseases (ASA>II)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary final study point is the polyethylene wear rates. Measuring is<br /><br>based on anterior-posterior (AP) radiographs at 3,12,24 and 60 months using a<br /><br>computer-assisted edge-detection system (ROGAN Delft, VPX ortho)<br /><br>The software calculates femoral head displacement (mm) as a representation of<br /><br>wear rate (mm/year) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pain level will be determined using a 10-point Visual Analog Scale (VAS), in<br /><br>which 0 implies no pain and 10 implies the worst possible pain.<br /><br><br /><br>4 questionnaires:<br /><br><br /><br>- Harris Hip Score: reflecting both function and pain<br /><br><br /><br>- The Short-Form 36 (SF-36): representing eight health domains that are<br /><br>combined into a physical and a mental component scale.<br /><br><br /><br>- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC):<br /><br>focusing on joint pain, stiffness and loss of function related to<br /><br>osteoarthritis of hip.<br /><br><br /><br>- Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH):<br /><br>Functional status and activity level<br /><br><br /><br><br /><br><br /><br>Complication rates: infection, neurovascular injury, malpositioning of the<br /><br>prosthesis, asceptic loosening of the prosthesis and dislocation.</p><br>