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Clinical Trials/NL-OMON40132
NL-OMON40132
Recruiting
Phase 4

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

Medisch Centrum Leeuwarden0 sites106 target enrollmentTBD
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Conditionssymptomatic coxarthrosis - wear of the hip joint1002321310005944

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
symptomatic coxarthrosis - wear of the hip joint
Sponsor
Medisch Centrum Leeuwarden
Enrollment
106
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Medisch Centrum Leeuwarden

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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