Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient-Specific Techniques for Hip Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03975673
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Centre de l'arthrose, Paris

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.

Condition or disease Intervention/treatment Phase
Hip Arthritis Hip Arthropathy Procedure: hip replacement Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective two-arms consecutive patients study
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Dislocation rate [ Time Frame: Occurrence within the first year after primary total hip replacement ]
    The rates of occurrence of hip dislocation (treated in the hospital or in an outpatient setting).


Secondary Outcome Measures :
  1. EuroQualityOfLife 5 dimension index (EQ5D) [ Time Frame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters. ]
    EQ5D is a generic QoL scale from -0.6 to 1

  2. Oxford hip score (OHS) [ Time Frame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters. ]
    OHS is a rate of hip function from 0 to 48

  3. satisfaction visual analogic scale (VAS) [ Time Frame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters. ]
    satisfaction is a VAS score from 0 to 100

  4. Implant positioning parameter [ Time Frame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters. ]
    Implant positioning parameters (inclination, version, offset) are computed on post-operative X rays acquisition.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975673


Contacts
Layout table for location contacts
Contact: Cedric Maillot +33611789158 cedric.maillot@sfr.fr

Sponsors and Collaborators
Centre de l'arthrose, Paris
Investigators
Layout table for investigator information
Principal Investigator: Cedric Maillot centre de l'arthrose

Layout table for additonal information
Responsible Party: Centre de l'arthrose, Paris
ClinicalTrials.gov Identifier: NCT03975673     History of Changes
Other Study ID Numbers: PST-HR
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre de l'arthrose, Paris:
hip arthroplasty
spine hip relation

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Joint Diseases
Musculoskeletal Diseases