Patient-Specific Techniques for Hip Replacement

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Arthritis; Hip Arthropathy
• Intervention / Treatment: Procedure: hip replacement

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

• Study Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cedric Maillot; Phone Number: +33611789158; Email: cedric.maillot@sfr.fr

Study Locations

• France
  • Paris, France, 75011
    • Recruiting
    • Université de Paris
    • Contact: cedric maillot, md; Phone Number: +11789158; Email: cedric.maillot@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Total Hip Replacement (cTHR ); 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; Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique
EXPERIMENTAL: Kinematically Aligned Total Hip Replacement (KATHR ); 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; Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Centre de l'arthrose, Paris
• Investigators: Principal Investigator: Cedric Maillot, Centre de l'arthrose

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (ACTUAL): June 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: hip arthroplasty; spine hip relation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: PST-HR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No