RecruitingNot Applicable

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

Czechia100 participantsStarted 2022-11-21

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum metal ion analysis (Cobalt)

Timeframe: 12 months after surgery

Serum metal ion analysis (Chromium)

Timeframe: 12 months after surgery

Trial details

NCT IDNCT05547984

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Lutz Dreyer, Dr.

+49746195 info@aesculap.de

View on ClinicalTrials.gov More Coxarthrosis; Primary trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.