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Patient-Specific Techniques for Hip Replacement

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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

Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date July 23, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03975673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient-Specific Techniques for Hip Replacement
Official Title  ICMJE Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective two-arms consecutive patients study
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hip Arthritis
  • Hip Arthropathy
Intervention  ICMJE Procedure: hip replacement
Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique
Study Arms  ICMJE
  • 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°)
    Intervention: Procedure: hip replacement
  • 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.
    Intervention: Procedure: hip replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2023
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cedric Maillot +33611789158 cedric.maillot@sfr.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975673
Other Study ID Numbers  ICMJE PST-HR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre de l'arthrose, Paris
Study Sponsor  ICMJE Centre de l'arthrose, Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cedric Maillot centre de l'arthrose
PRS Account Centre de l'arthrose, Paris
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP