Menu
Recruiting NCT05547984

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

No phase Interventional Coxarthrosis; Primary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual Mobility Cup, Standard Acetabular component.
Who it may be relevant to
Registry conditions: Coxarthrosis; Primary. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Device 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
  • 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

Primary outcome measures

  • Serum metal ion analysis (Cobalt) [Time frame: 12 months after surgery]
  • Serum metal ion analysis (Chromium) [Time frame: 12 months after surgery]
Secondary outcome measures (7)
  • Change of functional outcome over three year follow-up period (Harris Hip Score) [Time frame: 3 months, 12 months and 3 years postoperatively]
  • Gait analysis over time [Time frame: preoperative, 3 months and 12 months postoperatively]
  • Development of Patient satisfaction with surgery result over time [Time frame: at three examinations during Follow-Up (3 months postop, 1 year postop, 3 years postop)]
  • Radiologic Evaluation: Cup Inclination over time [Time frame: immediately postoperative, 3 months, 12 months and 3 years postoperative]
  • Radiologic Evaluation: center of rotation [Time frame: immediately postoperative, 3 months, 12 months and 3 years postoperative]
  • Radiologic Evaluation: Radiolucencies around the cup [Time frame: over follow-up period 3 months, 12 months and 3 years postoperative]
  • Radiological Outcome: Heterotopic Ossification [Time frame: over follow-up period 3 months, 12 months and 3 years postoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Masaryk Hospital — Ústí nad Labem

Identifiers

NCT: NCT05547984 · AAG-G-H-2203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗