Arthroplasty ComplicationsATHENSNCT05014932
Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem
An observational study of Arthroplasty Complications, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem. Retrospective and prospective multicentric study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty Complications
- How many people
- 531 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2022to 14 Mar 2023
- Phase
- Observational
- 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
Study population: Patients with at least two years of uncemented fourth generation ceramic/ceramic total hip replacement with customised femoral stem.
Who may be able to join
- Patient aged 18 years or older, who has been informed of the research
- Patient who has had a fourth generation ceramic/ceramic hip replacement implanted for at least two years as a first-line replacement
- Patient who has had a three-dimensional preoperative examination leading to the design and implantation of a custom femoral stem
- Patient regularly monitored since surgery and for whom all clinical and radiological data are available at the three-month and two-year follow-up visits
Who cannot join
- Patient operated for revision
- Patient under legal protection, guardianship or curators
- Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.
Retrospective and prospective multicentric study.
Read the detailed description
On a series of patients operated on for more than two years after a total hip arthroplasty that resulted in the implantation of a ceramic-on-ceramic prosthesis with a customized femoral stem:
Primary objective: To assess the frequency of occurrence of joint noise.
Secondary objectives:
- To describe the characteristics of the noise nuisance (date of onset, frequency, intensity, impact...)
- To evaluate the individual and surgical factors associated with the occurrence of noise pollution.
- Conditions
- Arthroplasty Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Noise nuisance
Percentage of occurrence of noise nuisance (assessed in relation to the total number of patients and the total number of prostheses).
The frequency of occurrence of noise nuisance will be analysed descriptively. The time elapsed until the occurrence of the noise nuisance will be additionally assessed by a Kaplan-Meier analysis.
Measured: 2 years
Secondary outcomes (4)
Oxford Score
The Oxford Hip Score questionnaire (OHS 12) consists of 12 questions. It measures pain (6 items) and hip function (6 items) in relation to activities of daily living such as walking, dressing and sleep disturbance. Each question has 5 possible answers. Each has a value from 0 to 4, with 0 representing the highest level of severity and 4 representing no or almost no symptoms.
Measured: 2 years
Hip disability and Osteoarthritis Outcome Score (HOOS) Score
The HOOS questionnaire is a self-administered questionnaire specific to hip arthroplasty. It consists of 40 questions with 5 domains: 5 questions on symptoms and stiffness; 10 questions on pain; 17 questions on functional results in daily life; 4 questions on sport and leisure activities; 4 questions on quality of life.
It includes 5 sub-scores, one sub-score per domain.
Measured: 2 years
Forgotten Joint Score
The Forgotten Joint Score (FJS-12) is a self-administered questionnaire consisting of 12 questions assessing the degree of forgetfulness of hip replacements in a given situation of daily life. Each answer is selected from a 5-point Likert scale with response options ranging from never (0) to most of the time (4).
Measured: 2 years
Prosthesis life span
The life span of the prosthesis is the time between the implantation of the prosthesis and its complete or partial surgical revision.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start18 Feb 2022
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis NOGIER, MD PD, Principal investigator, Clinique Maussins-Nollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014932
- Sponsor's protocol ID
- 2020-A02544-35
- Acronym
- ATHENS
- Status last verified
- Jun 2024
- First submitted
- 16 Aug 2021
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem
- ClinicalTrials.gov ID
- NCT05014932
- Acronym / sponsor ID
- ATHENS / 2020-A02544-35
- Conditions
- Arthroplasty Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 20 Aug 2021 (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.
Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.
Retrospective and prospective multicentric study.
Detailed description
On a series of patients operated on for more than two years after a total hip arthroplasty that resulted in the implantation of a ceramic-on-ceramic prosthesis with a customized femoral stem:
Primary objective: To assess the frequency of occurrence of joint noise.
Secondary objectives:
- To describe the characteristics of the noise nuisance (date of onset, frequency, intensity, impact...)
- To evaluate the individual and surgical factors associated with the occurrence of noise pollution.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with at least two years of uncemented fourth generation ceramic/ceramic total hip replacement with customised femoral stem.
Key inclusion criteria (4 listed)
- Patient aged 18 years or older, who has been informed of the research
- Patient who has had a fourth generation ceramic/ceramic hip replacement implanted for at least two years as a first-line replacement
- Patient who has had a three-dimensional preoperative examination leading to the design and implantation of a custom femoral stem
- Patient regularly monitored since surgery and for whom all clinical and radiological data are available at the three-month and two-year follow-up visits
Key exclusion criteria (3 listed)
- Patient operated for revision
- Patient under legal protection, guardianship or curators
- Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Noise nuisance
Time frame: 2 years
Percentage of occurrence of noise nuisance (assessed in relation to the total number of patients and the total number of prostheses). The frequency of occurrence of noise nuisance will be analysed descriptively. The time elapsed until the occurrence of the noise nuisance will be additionally assessed by a Kaplan-Meier analysis.
4 secondary outcomes
Oxford Score
Time frame: 2 years
Hip disability and Osteoarthritis Outcome Score (HOOS) Score
Time frame: 2 years
Forgotten Joint Score
Time frame: 2 years
Prosthesis life span
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
Alexis NOGIER, MD PD principal investigator
Clinique Maussins-Nollet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty Complications, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 1 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noise nuisance (time frame: 2 years). 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 1 Jul 2024.