Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol

Gonarthrosis Clinical Trial

— UKA-L2086  

Official title:

Evaluation of Functional Recovery of Patients Undergoing Medial Monocompartmental Knee Prosthesis With One Day Protocol Versus Fast Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302075
• Other study ID #: UKA-L2086
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
• Contact: Elena Cittera
• Phone: +39 0283502224
• Email: direzionescientifica iog [@]grupposandonato.it>
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis, Knee

Intervention

Other:
• One Day Rehabilitation
Patient discharged at home the day after the operation and carrying out outpatient rehabilitation according to the clinical standard
• Fast Rehabilitation
Patient 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

Locations

Country	Name	City	State
Italy	Istituto Clinico San Siro	Milan	Italia

Sponsors (1)

Lead Sponsor	Collaborator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome)	To evaluate the KSS at 1 month from the surgery	1 month