- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05547984
Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA) (CeMoD-prime)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefan Maenz, Dr.
- Phone Number: +49746195
- Email: info@aesculap.de
Study Locations
-
-
-
Ústí nad Labem, Czechia
- Recruiting
- Masaryk Hospital
-
Contact:
- Tomas Novotny, MuDr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dual Mobility Cup
dual mobility articulation
|
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:
|
Active Comparator: Standard Acetabular component
standard articulation with polyethylene + vitamin E inlay and metal head
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months after surgery
|
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
|
12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months, 12 months and 3 years postoperatively
|
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. |
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)
|
Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
|
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
|
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.
|
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
|
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.
|
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
|
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"
|
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
|
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
|
over follow-up period 3 months, 12 months and 3 years postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAG-G-H-2203
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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