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Patient-Specific Techniques for Hip Replacement

Primary Purpose

Hip Arthritis, Hip Arthropathy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hip replacement
Sponsored by
Centre de l'arthrose, Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthritis focused on measuring hip arthroplasty, spine hip relation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Université de ParisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Total Hip Replacement (cTHR )

Kinematically Aligned Total Hip Replacement (KATHR )

Arm 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°)

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.

Outcomes

Primary Outcome Measures

Dislocation rate
The rates of occurrence of hip dislocation (treated in the hospital or in an outpatient setting).

Secondary Outcome Measures

EuroQualityOfLife 5 dimension index (EQ5D)
EQ5D is a generic QoL scale from -0.6 to 1
Oxford hip score (OHS)
OHS is a rate of hip function from 0 to 48
satisfaction visual analogic scale (VAS)
satisfaction is a VAS score from 0 to 100
Implant positioning parameter
Implant positioning parameters (inclination, version, offset) are computed on post-operative X rays acquisition.

Full Information

First Posted
May 29, 2019
Last Updated
April 6, 2020
Sponsor
Centre de l'arthrose, Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03975673
Brief Title
Patient-Specific Techniques for Hip Replacement
Official Title
Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre de l'arthrose, Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthritis, Hip Arthropathy
Keywords
hip arthroplasty, spine hip relation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective two-arms consecutive patients study
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Total Hip Replacement (cTHR )
Arm Type
Active Comparator
Arm 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°)
Arm Title
Kinematically Aligned Total Hip Replacement (KATHR )
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
hip replacement
Intervention Description
Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique
Primary Outcome Measure Information:
Title
Dislocation rate
Description
The rates of occurrence of hip dislocation (treated in the hospital or in an outpatient setting).
Time Frame
Occurrence within the first year after primary total hip replacement
Secondary Outcome Measure Information:
Title
EuroQualityOfLife 5 dimension index (EQ5D)
Description
EQ5D is a generic QoL scale from -0.6 to 1
Time Frame
Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Title
Oxford hip score (OHS)
Description
OHS is a rate of hip function from 0 to 48
Time Frame
Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Title
satisfaction visual analogic scale (VAS)
Description
satisfaction is a VAS score from 0 to 100
Time Frame
Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Title
Implant positioning parameter
Description
Implant positioning parameters (inclination, version, offset) are computed on post-operative X rays acquisition.
Time Frame
Preoperative, postoperative 6 months and 12 months . assessment for all parameters.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cedric Maillot
Phone
+33611789158
Email
cedric.maillot@sfr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cedric Maillot
Organizational Affiliation
centre de l'arthrose
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Paris
City
Paris
ZIP/Postal Code
75011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
cedric maillot, md
Phone
+11789158
Email
cedric.maillot@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Patient-Specific Techniques for Hip Replacement

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