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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Enrolling

Conditions

Gonarthrosis

Treatments

Procedure: arthroplasty

Study type

Observational

Funder types

Other

Identifiers

NCT04460989

2020-A00075-34 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

480 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).