- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04460989
Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type (ESPACE)
August 16, 2021 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
480
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michel BONNIN, MD
- Phone Number: 33 04 37 53 00 26
- Email: bonnin.michel@gmail.com
Study Contact Backup
- Name: Tarik AIT SI SELMI, MD
- Phone Number: 33 04 37 53 07 04
- Email: tarik.aitsiselmi@gmail.com
Study Locations
-
-
-
Lyon, France, 69008
- Centre Orthopédique Santy
-
Contact:
- Michel BONNIN, MD
- Email: bonnin.michel@gmail.com
-
Contact:
- TARIK AIT SI SELMI, MD
- Email: tarik.aitsiselmi@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patient with uni or bilateral primary gonarthrosis
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
standard implant
arthroplasty with a standard implant
|
total knee replacement
|
personalized implant
arthroplasty with a customized implant
|
total knee replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF12 score at M24
Time Frame: 24 months
|
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.
|
24 months
|
KOOS Score at M24
Time Frame: 24 months
|
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.
|
24 months
|
Forgotten Joint Score at M24
Time Frame: 24 months
|
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.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: MICHEL BONNIN, MD, Centre Orthopédique Santy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
September 1, 2026
Study Completion (Anticipated)
September 1, 2026
Study Registration Dates
First Submitted
July 2, 2020
First Submitted That Met QC Criteria
July 2, 2020
First Posted (Actual)
July 8, 2020
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 16, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A00075-34 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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