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NCT Number: NCT05547984

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 THA in a cementless acetabular cup

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masaryk Hospital

Ústí nad Labem, Czechia

Location status: Recruiting

Location contact

Tomas Novotny, MuDr.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual Mobility Cup

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

Other names: Total Hip Arthroplasty

Standard Acetabular component

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

Other names: Total Hip Arthroplasty

Primary outcomes

  1. Serum metal ion analysis (Cobalt)

    Time frame: 12 months after surgery

    Cobalt ion levels in blood serum in measured in [µg/L], Comparison between the two groups

  2. Serum metal ion analysis (Chromium)

    Time frame: 12 months after surgery

    Chromium ion levels in blood serum in measured in [µg/L], Comparison between the two groups

Secondary outcomes

  1. Change of functional outcome over three year follow-up period (Harris Hip Score)

    Time frame: 3 months, 12 months and 3 years postoperatively

    The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100, any result <70 is considered a poor result; The HHS is an outcome measure administered by a qualified health care professional, such as a physician or a physical therapist.

  2. Gait analysis over time

    Time frame: preoperative, 3 months and 12 months postoperatively

    The gait lab analysis involves a high amount of recorded data and variables. Gait lab analyses are performed with the patients between the preoperative state, 3 months after surgery and 1 year postoperative. The Gait Profile Score (GPS) is used as a measure for the deviation in gait kinematics from a healthy patient population to compare the two treatment groups.

    Lower score values can be considered as a sign of better restoration of the physiological gait kinematics.

  3. 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)

    Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied

  4. Radiologic Evaluation: Cup Inclination over time

    Time frame: immediately postoperative, 3 months, 12 months and 3 years postoperative

    Inclination is the orientation of the cup in the coronal plane. The target acetabular cup inclination is a "safe zone" between 30-50° abduction (assessed on antero-posterior (ap) x-rays of the hip). The comparison of the intraoperatively achieved inclination and the inclination at different follow-up examinations allows prediction on longterm success.

  5. Radiologic Evaluation: center of rotation

    Time frame: immediately postoperative, 3 months, 12 months and 3 years postoperative

    Centre of Rotation (CoR) is defined as the zero position for the measurement of potential cup migration. Horizontal: Distance of CoR to ipsilateral teardrop; Vertical: Distance CoR to Inter-teardrop line; The comparison of the intraoperatively center of rotation and the center of rotation at different follow-up examinations allows prediction on longterm success.

  6. Radiologic Evaluation: Radiolucencies around the cup

    Time frame: over follow-up period 3 months, 12 months and 3 years postoperative

    Bony Osseointegration or conspicuous features of the cup are assessed on anterior-posterior and lateral x-rays of the cup and will be analysed according to the zones defined by Charnley. "Charnley" zones of the acetabular component are distinct zones used in assessment of aseptic loosening in total hip joint replacements. The radiolucencies are categorized to "none", "less than or equal to 2mm" and "more than 2 mm"

  7. Radiological Outcome: Heterotopic Ossification

    Time frame: over follow-up period 3 months, 12 months and 3 years postoperative

    Brooker classification divides heterotopic ossifications that form following total hip replacement to four classes. Class I: islands of bone within soft tissues around hip; Class II: bone spurs in pelvis or proximal end of femur leaving ≥1 cm between the opposing bone surfaces; Class III: bone spurs that extend from pelvis or the proximal end of femur, which reduce the space between the opposing bone surfaces to <1cm; Class IV: ankylosis of the hip on x-ray

Study contacts

Contact information is provided by the study sponsor or research team.

Lutz Dreyer, Dr.

CONTACT

[email protected]

+49746195

Stefan Maenz, Dr.

CONTACT

[email protected]

+49746195

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study 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

Acronym: CeMoD-prime

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Sep 21, 2022
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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