Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
A Randomized Controlled Trial Comparing Modular Dual Mobility Inserts With Ceramic Multilayer Coating Versus Standard Polyethylene Inserts for Primary Total Hip Arthroplasty (THA) in a Cementless Acetabular Cup
Aesculap AG
100 participants
Nov 21, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Primary coxarthrosis patients indicated for cementless total hip arthroplasty
- Written informed patient consent
Exclusion Criteria10
- 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
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Interventions
Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the Dual Mobility cup
Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the standard device with polyethylene + vitamin E inlay and metal head
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05547984