GonarthrosisESPACENCT04460989
Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type
An observational study of Gonarthrosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2021to 31 Oct 2025
- 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: Patient with uni or bilateral primary gonarthrosis
Who may be able to join
- Adult man or woman who has signed consent to participate in the study
- Patient with uni- or bilateral primary gonarthrosis
- For which an indication for total knee arthroplasty has been established
Who cannot join
- History of knee arthroplasty or osteotomy
- History of knee fracture
- Inflammatory rheumatic disease or any other progressive concomitant disease that may affect the patient's functional prognosis.
- Joint or extra-articular deformities of the lower limb of traumatic origin
- Neurological diseases, stroke sequelae
- Mental disability or any other reason that may hinder the understanding or strict application of the protocol
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- Patient not affiliated to the French social security scheme
- Patient under legal protection, guardianship or trusteeship
- Patient already included in another therapeutic study protocol or having participated in another trial within the previous three months
- Arthroplasty actually performed
- Absence of per operative complications in bone (femoral or tibial bone), ligament (rupture or disinsertion of the patellar or quadricipital tendon) or nerve (lesion of the external popliteal sciatica).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Orthopédique Santy
Lyon, 69008
Michel BONNIN, MD, bonnin.michel@gmail.com
TARIK AIT SI SELMI, MD, tarik.aitsiselmi@gmail.com
About this study
Official title: Evaluation of the Impact of Customization of Total Knee Prostheses on Patient Satisfaction and Functional Outcome of Arthroplasty.
The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty.
Read the detailed description
Prospective randomized monocentric prospective comparative study carried out as a single blind study on two parallel groups (standard implant or customized implant).
Secondary Objectives: Compare between groups :
- the functional outcome of the arthroplasty
- pain progression
- the evolution of the quality of life
- the conditions of the surgery (duration of surgery, length of hospitalization, blood loss)
- the frequency of adverse events related to arthroplasty
- Conditions
- Gonarthrosis
- Being tested
- arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroplastyProcedure or surgery
total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| standard implant | arthroplasty with a standard implant Receives: Procedure: arthroplasty | |
| personalized implant | arthroplasty with a customized implant Receives: Procedure: arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKS self-questionnaire Score at M24
The score obtained on the IKS self-questionnaire at 24 months will be compared between the two treatment groups by an analysis of covariance, with the basal IKS score as a covariate and the type of prosthesis as a factor.
Measured: 24 MONTHS
Secondary outcomes (3)
SF12 score at M24
The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.
Measured: 24 months
KOOS Score at M24
The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.
Measured: 24 months
Forgotten Joint Score at M24
The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start27 Oct 2021
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GonarthrosisStudies 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
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MICHEL BONNIN, MD, Principal investigator, CENTRE ORTHOPÉDIQUE SANTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460989
- Sponsor's protocol ID
- 2020-A00075-34
- Other IDs
- 2020-A00075-34
- Acronym
- ESPACE
- Status last verified
- Jun 2024
- First submitted
- 2 Jul 2020
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beel W, Sappey-Marinier E, Latifi R; ReSurg; Ait-Si-Selmi T, Bonnin MP. Individualised compared to off-the-shelf total knee arthroplasty results in lower and less variable patellar tilt. Knee Surg Sports Traumatol Arthrosc. 2024 Dec;32(12):3163-3173. doi: 10.1002/ksa.12234. Epub 2024 Jun 12.
PubMed 38864165Sappey-Marinier E, Beel W; ReSurg; Bonnin MP, Ait-Si-Selmi T. Better operating room efficiency and reduced staff demand: Individualised versus off-the-shelf total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2024 Dec;32(12):3174-3184. doi: 10.1002/ksa.12233. Epub 2024 Jun 12.
PubMed 38864156
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 the Impact of Customization of Total Knee Prostheses on Patient Satisfaction and Functional Outcome of Arthroplasty.
- ClinicalTrials.gov ID
- NCT04460989
- Acronym / sponsor ID
- ESPACE / 2020-A00075-34
- Conditions
- Gonarthrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 8 Jul 2020 (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.
The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty.
Detailed description
Prospective randomized monocentric prospective comparative study carried out as a single blind study on two parallel groups (standard implant or customized implant).
Secondary Objectives: Compare between groups :
- the functional outcome of the arthroplasty
- pain progression
- the evolution of the quality of life
- the conditions of the surgery (duration of surgery, length of hospitalization, blood loss)
- the frequency of adverse events related to arthroplasty
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard implant | – | Procedure: arthroplastyarthroplasty with a standard implant |
| personalized implant | – | Procedure: arthroplastyarthroplasty with a customized implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with uni or bilateral primary gonarthrosis
Key inclusion criteria (3 listed)
- Adult man or woman who has signed consent to participate in the study
- Patient with uni- or bilateral primary gonarthrosis
- For which an indication for total knee arthroplasty has been established
Key exclusion criteria (11 listed)
- History of knee arthroplasty or osteotomy
- History of knee fracture
- Inflammatory rheumatic disease or any other progressive concomitant disease that may affect the patient's functional prognosis.
- Joint or extra-articular deformities of the lower limb of traumatic origin
- Neurological diseases, stroke sequelae
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 |
|---|---|---|
| arthroplastytotal knee replacement | Procedure or surgery | personalized implant, standard implant |
Primary outcome
IKS self-questionnaire Score at M24
Time frame: 24 MONTHS
The score obtained on the IKS self-questionnaire at 24 months will be compared between the two treatment groups by an analysis of covariance, with the basal IKS score as a covariate and the type of prosthesis as a factor.
3 secondary outcomes
SF12 score at M24
Time frame: 24 months
KOOS Score at M24
Time frame: 24 months
Forgotten Joint Score at M24
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 38864165Beel W, Sappey-Marinier E, Latifi R; ReSurg; Ait-Si-Selmi T, Bonnin MP. Individualised compared to off-the-shelf total knee arthroplasty results in lower and less variable patellar tilt. Knee Surg Sports Traumatol Arthrosc. 2024 Dec;32(12):3163-3173. doi: 10.1002/ksa.12234. Epub 2024 Jun 12.
- Derived from this study: PubMed 38864156Sappey-Marinier E, Beel W; ReSurg; Bonnin MP, Ait-Si-Selmi T. Better operating room efficiency and reduced staff demand: Individualised versus off-the-shelf total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2024 Dec;32(12):3174-3184. doi: 10.1002/ksa.12233. Epub 2024 Jun 12.
- 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.
MICHEL BONNIN, MD principal investigator
CENTRE ORTHOPÉDIQUE SANTY
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 Gonarthrosis, 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 3 inclusion and 11 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel BONNIN, MD (04 37 53 00 26 ext. 33, bonnin.michel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKS self-questionnaire Score at M24 (time frame: 24 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460989, which also lists 2 linked publications.
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.