Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302075
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-04
Brief Title:
Functional Recovery After Medial Monocompartmental Knee Prosthesis One Day Protocol Versus Fast Protocol
Sponsor:
IRCCS Ospedale Galeazzi-SantAmbrogio
Organization:
IRCCS Ospedale Galeazzi-SantAmbrogio
Study Overview
Official Title:
Evaluation of Functional Recovery of Patients Undergoing Medial Monocompartmental Knee Prosthesis With One Day Protocol Versus Fast Protocol
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UKA-L2086
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None