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

Not Applicable
Recruiting
Conditions
Gonarthrosis
Interventions
Other: One Day Rehabilitation
Other: Fast Rehabilitation
Registration Number
NCT06302075
Lead Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Brief 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).

Detailed 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 & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
One Day RehabilitationOne Day Rehabilitationdischarged home the day after the operation (24 hours) and carrying out outpatient rehabilitation according to the clinical standard
Fast RehabilitationFast Rehabilitationdischarged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard
Primary Outcome Measures
NameTimeMethod
Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome)1 month

To evaluate the KSS at 1 month from the surgery

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Istituto Clinico San Siro

🇮🇹

Milan, Italia, Italy

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