Patient-Specific Techniques for Hip Replacement

Study Overview
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Brief Summary
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Background In the 19th century, Sir John Charnley successfully introduced total joint replacements for hips. In order to prevent implant fixation failure and accelerated polyethylene wear, it was initially recommended that implants were systematically positioned in a biomechanically-friendly way, which disregarded most of the individual anatomy (medialized acetabular cup, systematized cup version and inclination, etc.) While those initial surgical techniques made popular and clinically successful total joint replacements, many complications (aseptic loosening, pain, excessive wear) have remained and mainly the persistence of frequent instability after THA. In response to those complications, many improvements were developed in the area of joint replacement over the last few decades, with one the most recent dating from 2017 and being the development of a surgical technique Rationale The kinematic alignment (KA) technique for total hip arthroplasty (THA) aims at restoring the acetabular center of rotation and as much as possible the constitutional acetabular anteversion by using the transverse acetabular ligament (TAL) as a reference landmark. Also, the technique aims (1) at making personalized choice for the hip component design, (2) at defining the cup positioning, and (3) at sometimes considering additional spine surgery based on the assessment of the individual spine-hip relation. KA techniques for hip replacements are relatively new, likely to become popular over time, and their true value remains to be determined.

Detailed Description
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Objective: Evaluation of the kinematic alignment technique for hip prostheses in patient with hip osteoarthritis Hypothesis: the consideration of hip pathoanatomy and lumbo-pelvic kinematic disorder when planning a hip replacement is likely to decrease the risk of prosthetic dislocation and improve patient function and satisfaction

Official Title
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Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study

Conditions
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Hip Arthritis, Hip Arthropathy

Intervention / Treatment
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* Procedure: hip replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritic hip patients eligible for primary total hip arthroplasty (THR). > 18 years-old with no upper age limit Affiliated to a social security scheme Exclusion Criteria: Pregnant or lactating women or in age to procreate without contraceptive treatment History of mental illness or neurological deficit or adults lacking capacity to consent for themselves Prisoners or young offenders Persons who might not adequately understand verbal explanations or written information given in French, or who have special communication needs Subjects having been or being frequently x-ray examination Heart failure with risk of exercise angina or comorbidity(ies) significantly affecting patient function Any participants who are involved in current research or have recently been involved in any research prior to recruitment.

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective two-arms consecutive patients study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Total Hip Replacement (cTHR )<br>Osteoarthritic patient undergoing the conventional technique medializing the hip center of rotation obtain a standing acetabular cup position fitting the Lewinneck recommendations (inclination 40°±10°, version 15°±10°) | Procedure: hip replacement<br>* Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique<br>|
| Experimental: Kinematically Aligned Total Hip Replacement (KATHR )<br>Osteoarthritic patient undergoing the kinematically aligned technique restoring the acetabular center of rotation restoring the constitutional acetabular anteversion by using the transverse acetabular ligament (TAL) as a reference landmark. making personalized choice for the hip component design considering additional spine surgery based on the assessment of the individual spine-hip relation. | Procedure: hip replacement<br>* Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dislocation rate | The rates of occurrence of hip dislocation (treated in the hospital or in an outpatient setting). | Occurrence within the first year after primary total hip replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQualityOfLife 5 dimension index (EQ5D) | EQ5D is a generic QoL scale from -0.6 to 1 | Preoperative, postoperative 6 months and 12 months . assessment for all parameters. | 
| Oxford hip score (OHS) | OHS is a rate of hip function from 0 to 48 | Preoperative, postoperative 6 months and 12 months . assessment for all parameters. | 
| satisfaction visual analogic scale (VAS) | satisfaction is a VAS score from 0 to 100 | Preoperative, postoperative 6 months and 12 months . assessment for all parameters. | 
| Implant positioning parameter | Implant positioning parameters (inclination, version, offset) are computed on post-operative X rays acquisition. | Preoperative, postoperative 6 months and 12 months . assessment for all parameters. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip arthroplasty, spine hip relation