Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair

Study Overview
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Brief Summary
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The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic.

Official Title
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Multicentric Observational Study Evaluating Clinical and Radiological Results of a Total Hip Arthroplasty Using a Ceramic Friction Pair

Conditions
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Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient implanted with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup. Aged of more than 18 years at the time of the surgery. Patient with a follow-up of at least 2 years after surgery based on a consecutive and exhaustive series of patients operated within the inclusion period. Able to understand information to participate to the study. Exclusion Criteria: Patient having a tumoral pathology. Patient having expressed opposition to the study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total hip replacement using a ceramic friction pair<br>Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Surgical incidents. Post-operative complications. Failure and revisions analysis. | 2-year follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Performance: Mobility | Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°). Normal values (usually observed range of motions) are: extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°). Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion. | Baseline | 
| General Performance: Mobility | Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°). Normal values (usually observed range of motions) are: extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°). Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion. | 2-year Follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Hip Replacement, Ceramic, Acetabular cup, Femoral stem