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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40132

Enrollment

106

Registered

2015-04-20

Start date

2015-07-03

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

symptomatic coxarthrosis - wear of the hip joint

Interventions

Patients will receive a cemented total hip arthroplasty: F.A.L. cup and SPII stem Group 1: crosslinked polyethylene F.A.L. cup and SPII stem Group 2: standard polyethylene F.A.L. cup and SPII stem

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Mean linear wear of the cross-linked polyethylene F.A.L. cup compared to the mean linear wear of the standard polyethylene F.A.L. cup at 5 years postoperatively.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)