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Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)

RECRUITINGN/ASponsored by Aesculap AG
Actively Recruiting
PhaseN/A
SponsorAesculap AG
Started2022-11-21
Est. completion2027-09
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Primary coxarthrosis patients indicated for cementless total hip arthroplasty
* Written informed patient consent

Exclusion Criteria:

* Hip trauma or revision surgery
* Rheumatoid or neurologic disease
* BMI \>35
* Ongoing oncologic therapy
* Preoperatively elevated Co or Cr serum levels \>1.0 µg/L
* Patients with other joint implants, or anticipated need for another joint replacement surgery within the study period
* Acetabular cup size \<52 expected
* Patients not able to mentally or physically comply with the study demands and follow-up visits
* Patients \<18 years at surgery
* Pregnancy

Conditions2

ArthritisCoxarthrosis; Primary

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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