CeMoD-prime: Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dual Mobility Cup dual mobility articulation |
Device: Total Hip Arthroplasty
Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis.
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| Active Comparator: Standard Acetabular component standard articulation with polyethylene + vitamin E inlay and metal head |
Device: Total Hip Arthroplasty
Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis.
|
Outcome Measures
Primary Outcome Measures
- Serum metal ion analysis [12 months after surgery]
Cobalt and chromium ion levels in blood serum, comparison between the two groups
Secondary Outcome Measures
- Change of functional outcome over three year follow-up period (Harris Hip Score) [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.
- Gait analysis over time [preoperative, 3 months and 12 months postoperatively]
The gait lab analysis involves a high amount of recorded data and variables. (Gait profile scores and relevant subscores). These movement variables are compared between the preoperative state, 3 months after surgery and 1 year postoperative.
- Development of Patient satisfaction with surgery result over time [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
- Radiologic Evaluation: Cup Inclination over time [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.
- Radiologic Evaluation: center of rotation [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.
- Radiologic Evaluation: Radiolucencies around the cup [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"
- Radiological Outcome: Heterotopic Ossification [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary coxarthrosis patients indicated for cementless total hip arthroplasty
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Written informed patient consent
Exclusion Criteria:
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Hip trauma or revision surgery
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Rheumatoid or neurologic disease
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BMI >35
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Ongoing oncologic therapy
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Preoperatively elevated Co or Cr serum levels >1.0 µg/L
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Patients with other joint implants, or anticipated need for another joint replacement surgery within the study period
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Acetabular cup size <52 expected
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Patients not able to mentally or physically comply with the study demands and follow-up visits
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Patients <18 years at surgery
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Masaryk Hospital | Ústí nad Labem | Czechia |
Sponsors and Collaborators
- Aesculap AG
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAG-G-H-2203