Patient-Specific Techniques for Hip Replacement

Centre de l'arthrose, Paris

Status: Unknown

Conditions: Hip Arthropathy; Hip Arthritis

Treatments: Procedure: hip replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT03975673

PST-HR

Details and patient eligibility

About

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.

Full 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

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 2 patient groups

Conventional Total Hip Replacement (cTHR )

Active Comparator group

Description:

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°)

Treatment:

Procedure: hip replacement

Kinematically Aligned Total Hip Replacement (KATHR )

Experimental group

Description:

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.

Treatment:

Procedure: hip replacement