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

NCT ID: NCT05547984

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-21

Study Completion Date

2028-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Coxarthrosis; Primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dual Mobility Cup

dual mobility articulation

Group Type EXPERIMENTAL

Dual Mobility Cup

Intervention Type DEVICE

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

Standard Acetabular component

standard articulation with polyethylene + vitamin E inlay and metal head

Group Type ACTIVE_COMPARATOR

Standard Acetabular component

Intervention Type DEVICE

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

Interventions

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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 Dual Mobility cup

Intervention Type DEVICE

Standard Acetabular component

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

Intervention Type DEVICE

Other Intervention Names

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Total Hip Arthroplasty Total Hip Arthroplasty

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Masaryk Hospital

Ústí nad Labem, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Lutz Dreyer, Dr.

Role: CONTACT

[email protected]
+49746195

Stefan Maenz, Dr.

Role: CONTACT

[email protected]
+49746195

Facility Contacts

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Tomas Novotny, MuDr.

Role: primary

Other Identifiers

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AAG-G-H-2203

Identifier Type: -

Identifier Source: org_study_id