Back to resultsCeramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA) (CeMoD-prime)
Primary Purpose
Coxarthrosis; Primary
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Dual Mobility Cup
Standard Acetabular component
Sponsored by
About this trial
This is an interventional treatment trial for Coxarthrosis; Primary focused on measuring Dual Mobility Cup, Total Hip Arthroplasty
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
Sites / Locations
- Masaryk HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dual Mobility Cup
Standard Acetabular component
Arm Description
dual mobility articulation
standard articulation with polyethylene + vitamin E inlay and metal head
Outcomes
Primary Outcome Measures
Serum metal ion analysis (Cobalt)
Cobalt ion levels in blood serum in measured in [µg/L], Comparison between the two groups
Serum metal ion analysis (Chromium)
Chromium ion levels in blood serum in measured in [µg/L], Comparison between the two groups
Secondary Outcome Measures
Change of functional outcome over three year follow-up period (Harris Hip Score)
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.
Gait analysis over time
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.
Development of Patient satisfaction with surgery result over time
Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Radiologic Evaluation: Cup Inclination over time
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.
Radiologic Evaluation: center of rotation
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.
Radiologic Evaluation: Radiolucencies around the cup
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"
Radiological Outcome: Heterotopic Ossification
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05547984
Brief Title
Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
Acronym
CeMoD-prime
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis; Primary
Keywords
Dual Mobility Cup, Total Hip Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual Mobility Cup
Arm Type
Experimental
Arm Description
dual mobility articulation
Arm Title
Standard Acetabular component
Arm Type
Active Comparator
Arm Description
standard articulation with polyethylene + vitamin E inlay and metal head
Intervention Type
Device
Intervention Name(s)
Dual Mobility Cup
Other Intervention Name(s)
Total Hip Arthroplasty
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Standard Acetabular component
Other Intervention Name(s)
Total Hip Arthroplasty
Intervention Description
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 Measure Information:
Title
Serum metal ion analysis (Cobalt)
Description
Cobalt ion levels in blood serum in measured in [µg/L], Comparison between the two groups
Time Frame
12 months after surgery
Title
Serum metal ion analysis (Chromium)
Description
Chromium ion levels in blood serum in measured in [µg/L], Comparison between the two groups
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Change of functional outcome over three year follow-up period (Harris Hip Score)
Description
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.
Time Frame
3 months, 12 months and 3 years postoperatively
Title
Gait analysis over time
Description
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.
Time Frame
preoperative, 3 months and 12 months postoperatively
Title
Development of Patient satisfaction with surgery result over time
Description
Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Time Frame
at three examinations during Follow-Up (3 months postop, 1 year postop, 3 years postop)
Title
Radiologic Evaluation: Cup Inclination over time
Description
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.
Time Frame
immediately postoperative, 3 months, 12 months and 3 years postoperative
Title
Radiologic Evaluation: center of rotation
Description
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.
Time Frame
immediately postoperative, 3 months, 12 months and 3 years postoperative
Title
Radiologic Evaluation: Radiolucencies around the cup
Description
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"
Time Frame
over follow-up period 3 months, 12 months and 3 years postoperative
Title
Radiological Outcome: Heterotopic Ossification
Description
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
Time Frame
over follow-up period 3 months, 12 months and 3 years postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Maenz, Dr.
Phone
+49746195
Email
info@aesculap.de
Facility Information:
Facility Name
Masaryk Hospital
City
Ústí nad Labem
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Novotny, MuDr.
12. IPD Sharing Statement
Learn more about this trial
Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
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