Clinical trial NCT03975673: Patient-Specific Techniques for Hip Replacement
Official title: Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Arthritis
Hip Arthropathy
Keywords: hip arthroplasty
spine hip relation
Lead sponsor: Centre de l'arthrose, Paris
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective two-arms consecutive patients study
Primary purpose: TREATMENT

Brief summary: 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: * 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

Eligibility criteria: 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.

Primary outcomes:
measure: Dislocation rate
timeFrame: Occurrence within the first year after primary total hip replacement
Secondary outcomes:
measure: EuroQualityOfLife 5 dimension index (EQ5D)
timeFrame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
measure: Oxford hip score (OHS)
timeFrame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
measure: satisfaction visual analogic scale (VAS)
timeFrame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
measure: Implant positioning parameter
timeFrame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Other outcomes:
Locations:
city: Paris
country: France
facility: Université de Paris
Study officials:
affiliation: centre de l'arthrose
name: Cedric Maillot
role: PRINCIPAL_INVESTIGATOR
References: