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Clinical Trials/NCT06302075
NCT06302075
Recruiting
N/A

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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 site in 1 country50 target enrollmentNovember 16, 2021
ConditionsGonarthrosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gonarthrosis
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Enrollment
50
Locations
1
Primary Endpoint
Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 16, 2021
End Date
December 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome)

Time Frame: 1 month

To evaluate the KSS at 1 month from the surgery

Study Sites (1)

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