Patient-Specific Techniques for Hip Replacement

Hip Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03975673
• Other study ID #: PST-HR
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2020
• Source: Centre de l'arthrose, Paris
• Contact: Cedric Maillot
• Phone: +33611789158
• Email: cedric.maillot[@]sfr.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis
• Hip Arthropathy
• Joint Diseases

Intervention

Procedure:
• hip replacement
Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique

Locations

Country	Name	City	State
France	Université de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre de l'arthrose, Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dislocation rate	The rates of occurrence of hip dislocation (treated in the hospital or in an outpatient setting).	Occurrence within the first year after primary total hip replacement
Secondary	EuroQualityOfLife 5 dimension index (EQ5D)	EQ5D is a generic QoL scale from -0.6 to 1	Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Secondary	Oxford hip score (OHS)	OHS is a rate of hip function from 0 to 48	Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Secondary	satisfaction visual analogic scale (VAS)	satisfaction is a VAS score from 0 to 100	Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Secondary	Implant positioning parameter	Implant positioning parameters (inclination, version, offset) are computed on post-operative X rays acquisition.	Preoperative, postoperative 6 months and 12 months . assessment for all parameters.