Hip ArthritisNCT03975673
Patient-Specific Techniques for Hip Replacement
A study testing hip replacement in people with Hip Arthritis and Hip Arthropathy, run by Centre de l'arthrose, Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthritis, Hip Arthropathy
- What is being tested?
- hip replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritic hip patients eligible for primary total hip arthroplasty (THR).
- > 18 years-old with no upper age limit
- Affiliated to a social security scheme
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Université de Paris
Paris, 75011
cedric maillot, md, +11789158, cedric.maillot@aphp.fr
About this study
Official title: Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study
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
- Conditions
- Hip Arthritis, Hip Arthropathy
- Being tested
- hip replacement
- Keywords
- hip arthroplasty, spine hip relation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip replacementProcedure or surgery
Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique
| Study group | Role | What they receive |
|---|---|---|
| Conventional Total Hip Replacement (cTHR ) | Active comparator | 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°) Receives: Procedure: hip replacement |
| Kinematically Aligned Total Hip Replacement (KATHR ) | Experimental | 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. Receives: Procedure: hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dislocation rate
The rates of occurrence of hip dislocation (treated in the hospital or in an outpatient setting).
Measured: Occurrence within the first year after primary total hip replacement
Secondary outcomes (4)
EuroQualityOfLife 5 dimension index (EQ5D)
EQ5D is a generic QoL scale from -0.6 to 1
Measured: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Oxford hip score (OHS)
OHS is a rate of hip function from 0 to 48
Measured: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
satisfaction visual analogic scale (VAS)
satisfaction is a VAS score from 0 to 100
Measured: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Implant positioning parameter
Implant positioning parameters (inclination, version, offset) are computed on post-operative X rays acquisition.
Measured: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jan 2020
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective two-arms consecutive patients study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de l'arthrose, Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cedric Maillot, Principal investigator, centre de l'arthrose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975673
- Sponsor's protocol ID
- PST-HR
- Status last verified
- Apr 2020
- First submitted
- 29 May 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic vs Mechanical Alignment Technique for Primary Total Hip Replacement in Patient With Hip Arthritis: a Prospective Comparative Non Randomised Study
- ClinicalTrials.gov ID
- NCT03975673
- Acronym / sponsor ID
- PST-HR
- Conditions
- Hip Arthritis, Hip Arthropathy
- Keywords
- hip arthroplasty, spine hip relation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Centre de l'arthrose, ParisUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective two-arms consecutive patients study
| Arm | Type | Receives |
|---|---|---|
| Conventional Total Hip Replacement (cTHR ) | Active comparator | Procedure: hip replacementOsteoarthritic 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°) |
| Kinematically Aligned Total Hip Replacement (KATHR ) | Experimental | Procedure: hip replacementOsteoarthritic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Osteoarthritic hip patients eligible for primary total hip arthroplasty (THR).
- > 18 years-old with no upper age limit
- Affiliated to a social security scheme
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hip replacementOsteoarthritic patient undergoing the conventional technique or the kinematically aligned technique | Procedure or surgery | Conventional Total Hip Replacement (cTHR ), Kinematically Aligned Total Hip Replacement (KATHR ) |
Primary outcome
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).
4 secondary outcomes
EuroQualityOfLife 5 dimension index (EQ5D)
Time frame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Oxford hip score (OHS)
Time frame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
satisfaction visual analogic scale (VAS)
Time frame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Implant positioning parameter
Time frame: Preoperative, postoperative 6 months and 12 months . assessment for all parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cedric Maillot principal investigator
centre de l'arthrose
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hip replacement in people with Hip Arthritis and Hip Arthropathy, run by Centre de l'arthrose, Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cedric Maillot (+33611789158, cedric.maillot@sfr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dislocation rate (time frame: Occurrence within the first year after primary total hip replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020; AzTrials last refreshed its copy on 28 Oct 2026.