Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol (UKA-L2086)

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Enrolling

Conditions: Gonarthrosis

Treatments: Other: One Day Rehabilitation; Other: Fast Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06302075

UKA-L2086

Details and patient eligibility

About

The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).

Full description

The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).

The difference will be evaluated with the Knee Society Scopre (KSS) questionnaire at 1 month after the operation.

The population is made up of two groups of patients:

25 patients Group A: one day protocol; experimental group discharged home the day (24h) after the operation and carrying out rehabilitation according to the clinical standard 25 patients Group B: fast protocol; control group discharged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard

The subjects will undergo the following assessments:

• Pre-admission
• Knee replacement surgery
• Rehabilitation
• Questionnaires and evaluation scales at 7 and 15 days (+/- 2 days), at 1, 3, 6 months (+/- 7 days) and 12 months (+/- 1 month) after surgery. If necessary, they can be collected by telephone.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40<x<85 included
• Medial monocompartmental gonarthrosis grade 3-4 sec Kellgren-Lawrence
• Primary medial gonarthrosis
• Signing of the Informed Consent and consent to collaborate in all study procedures.

Exclusion criteria

• Cognitive decline
• Psychiatric disorders
• Neuromuscular disorders
• Age > 85 years or <40
• Lateral gonarthrosis grade 3-4 sec Kellgren-Lawrence
• Patella symptoms
• Secondary medial gonarthrosis
• Minor age
• Pregnant women (self-declaration)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

One Day Rehabilitation

Experimental group

Description:

discharged home the day after the operation (24 hours) and carrying out outpatient rehabilitation according to the clinical standard

Treatment:

Other: One Day Rehabilitation

Fast Rehabilitation

Active Comparator group

Description:

discharged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard

Treatment:

Other: Fast Rehabilitation