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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-27

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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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

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Gonarthrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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standard implant

arthroplasty with a standard implant

arthroplasty

Intervention Type PROCEDURE

total knee replacement

personalized implant

arthroplasty with a customized implant

arthroplasty

Intervention Type PROCEDURE

total knee replacement

Interventions

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arthroplasty

total knee replacement

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No