Clinical trial NCT05547984: Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coxarthrosis; Primary
Keywords: Dual Mobility Cup
Total Hip Arthroplasty
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: Serum metal ion analysis (Cobalt)
timeFrame: 12 months after surgery
measure: Serum metal ion analysis (Chromium)
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Change of functional outcome over three year follow-up period (Harris Hip Score)
timeFrame: 3 months, 12 months and 3 years postoperatively
measure: Gait analysis over time
timeFrame: preoperative, 3 months and 12 months postoperatively
measure: Development of Patient satisfaction with surgery result over time
timeFrame: at three examinations during Follow-Up (3 months postop, 1 year postop, 3 years postop)
measure: Radiologic Evaluation: Cup Inclination over time
timeFrame: immediately postoperative, 3 months, 12 months and 3 years postoperative
measure: Radiologic Evaluation: center of rotation
timeFrame: immediately postoperative, 3 months, 12 months and 3 years postoperative
measure: Radiologic Evaluation: Radiolucencies around the cup
timeFrame: over follow-up period 3 months, 12 months and 3 years postoperative
measure: Radiological Outcome: Heterotopic Ossification
timeFrame: over follow-up period 3 months, 12 months and 3 years postoperative
Other outcomes:
Locations:
city: Ústí nad Labem
country: Czechia
facility: Masaryk Hospital
Study officials:
References: