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

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

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Contact Backup

Study Locations

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

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.

Clinical Trials on Gonarthrosis

Clinical Trials on arthroplasty

Subscribe