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Patient-Specific Techniques for Hip Replacement

Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03975673
Enrollment
460
Registered
2019-06-05
Start date
2020-01-01
Completion date
2023-07-01
Last updated
2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthritis, Hip Arthropathy

Keywords

hip arthroplasty, spine hip relation

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

Interventions

PROCEDUREhip replacement

Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique

Sponsors

Centre de l'arthrose, Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Prospective two-arms consecutive patients study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Dislocation rateOccurrence within the first year after primary total hip replacementThe rates of occurrence of hip dislocation (treated in the hospital or in an outpatient setting).

Secondary

MeasureTime frameDescription
EuroQualityOfLife 5 dimension index (EQ5D)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)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)Preoperative, postoperative 6 months and 12 months . assessment for all parameters.satisfaction is a VAS score from 0 to 100
Implant positioning parameterPreoperative, postoperative 6 months and 12 months . assessment for all parameters.Implant positioning parameters (inclination, version, offset) are computed on post-operative X rays acquisition.

Countries

France

Contacts

Primary ContactCedric Maillot
cedric.maillot@sfr.fr+33611789158

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026