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

Aesculap

Status: Enrolling

Conditions: Coxarthrosis; Primary

Treatments: Device: Standard Acetabular component; Device: Dual Mobility Cup

Study type: Interventional

Funder types: Industry

Identifiers

NCT05547984

AAG-G-H-2203

Details and patient eligibility

About

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

Full description

The aim of this study is to show in a randomized controlled trial that cobalt and chromium ion serum levels are comparable to the metal ion levels in patients with standard articulation with metal head. The metal on polyethylene articulation is accepted as standard articulation since many decades, and which is currently in the Czech Republic the most used combination. Most studies which focused on the topic of metal ion release from modular dual mobility systems do not present results of a control group with standard articulation hip implants.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Dual Mobility Cup

Experimental group

Description:

dual mobility articulation

Treatment:

Device: Dual Mobility Cup

Standard Acetabular component

Active Comparator group

Description:

standard articulation with polyethylene + vitamin E inlay and metal head

Treatment:

Device: Standard Acetabular component