Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type

Gonarthrosis Clinical Trial

— ESPACE  

Official title:

Evaluation of the Impact of Customization of Total Knee Prostheses on Patient Satisfaction and Functional Outcome of Arthroplasty.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04460989
• Other study ID #: 2020-A00075-34
• Secondary ID: 2020-A00075-34
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: September 2026

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Michel BONNIN, MD
• Phone: 04 37 53 00 26
• Email: bonnin.michel[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis, Knee

Intervention

Procedure:
• arthroplasty
total knee replacement

Locations

Country	Name	City	State
France	Centre Orthopédique Santy	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 MONTHS
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months