Patient-Specific Techniques for Hip Replacement

NCT03975673 | Unknown

• 1 other identifier: PST-HR
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthritis; Hip Arthropathy

Keywords

hip arthroplasty; spine hip relation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• EuroQualityOfLife 5 dimension index (EQ5D)

  Preoperative, postoperative 6 months and 12 months . assessment for all parameters.

• Oxford hip score (OHS)

  Preoperative, postoperative 6 months and 12 months . assessment for all parameters.

• satisfaction visual analogic scale (VAS)

  Preoperative, postoperative 6 months and 12 months . assessment for all parameters.

• Implant positioning parameter

  Preoperative, postoperative 6 months and 12 months . assessment for all parameters.

Study Arms (2)

Conventional Total Hip Replacement (cTHR )

ACTIVE COMPARATOR

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

Kinematically Aligned Total Hip Replacement (KATHR )

EXPERIMENTAL

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

Interventions

hip replacement PROCEDURE

Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique

Conventional Total Hip Replacement (cTHR ); Kinematically Aligned Total Hip Replacement (KATHR )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritic hip patients eligible for primary total hip arthroplasty (THR).
• \> 18 years-old with no upper age limit
• Affiliated to a social security scheme

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de l'arthrose, Paris: lead

Study Sites (1)

Université de Paris

Paris, 75011, France

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Cedric Maillot

  centre de l'arthrose

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cedric Maillot

CONTACT

+33611789158; cedric.maillot@sfr.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective two-arms consecutive patients study

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 5, 2019
• Study Start: January 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2023
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)