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Status unknownNCT03975673Updated Apr 7, 2020

Patient-Specific Techniques for Hip Replacement

An interventional study of hip replacement in Hip Arthritis and Hip Arthropathy, sponsored by Centre de l'arthrose, Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-07.

Sponsored by Centre de l'arthrose, Paris · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
460
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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
02

Conditions studied

  • Hip Arthritis
  • Hip Arthropathy

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Keywords

  • hip arthroplasty
  • spine hip relation
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 460 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Centre de l'arthrose, Paris is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
460 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Procedurehip replacement

    Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique

06

What researchers measure

Primary outcomes

  1. Dislocation rate

    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 outcomes

  1. EuroQualityOfLife 5 dimension index (EQ5D)

    EQ5D is a generic QoL scale from -0.6 to 1

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

  2. Oxford hip score (OHS)

    OHS is a rate of hip function from 0 to 48

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

  3. satisfaction visual analogic scale (VAS)

    satisfaction is a VAS score from 0 to 100

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

  4. Implant positioning parameter

    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.

07

Study locations

1 of 1 sites recruiting
  • Université de Paris
    Paris, 75011, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03975673
Lead sponsor
Centre de l'arthrose, Paris
Responsible party
Sponsor
First posted
Jun 5, 2019
Start date
Jan 1, 2020
Primary completion
Jul 1, 2020 (estimated)
Completion
Jul 1, 2023 (estimated)
Last update
Apr 7, 2020

Study contacts

Cedric Maillot
Contact
cedric.maillot@sfr.fr
+33611789158
Cedric Maillot
principal investigator · centre de l'arthrose

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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