Wear analysis of cross-linked versus standard polyethylene F.A.L. acetabular cups in patiënts with symptomatic coxarthrosis: a randomized controlled trial

Phase 4

Recruiting

Conditions: symptomatic coxarthrosis - wear of the hip joint
10023213
10005944

Registration Number: NL-OMON40132

Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 106

Inclusion Criteria

1. Age 65 - 80 years
2. Symptomatic coxarthrosis and an indication for a cemented total hip prothesis
3. Physically and mentally able to attend the postoperative follow-up evaluations
4. Signed informed consent form

Exclusion Criteria

1. Standard contraindications to elective (un)cemented total hip athroplasties
2. Neurological disorders that affect walking
3. Physical or mental disabilities that could affect judgment or filling out the questionnaires
4. Not literate in Dutch
5. Body Mass Index > 40
6. An abnormal hip anatomy because of which the F.A.L. cup and SPII stem cannot be placed
7. Amputation of het lower extremity
8. Malignancies and currently receiving cytostatic therapy
9. Participation in another study that conflicts with the F.A.L.cup trial
10. Addiction to drugs or alcohol
11. Cup inclination of > 55 degrees

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean linear wear of the cross-linked polyethylene F.A.L. cup compared to the<br /><br>mean linear wear of the standard polyethylene F.A.L. cup at 5 years<br /><br>postoperatively. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. mean linear wear (millimeters/year) at 1 year, 3 years and 10 years<br /><br>postoperatively<br /><br>2. patient reported outcome measures (HOOS-PS, Oxford Hip Score, pain score,<br /><br>EQ5D and the SQUASH) at 1 year, 3 years 5 years and 10 years postoperatively<br /><br>3. number of periprosthetic radiolucencies at 5 years and 10 years<br /><br>postoperatively<br /><br>4. survival of the implant at 5 years and 10 years postoperatively<br /><br>5. total inpatient costs 10 years postoperatively</p><br>