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

March 8, 2024 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One Day Rehabilitation
discharged home the day after the operation (24 hours) and carrying out outpatient rehabilitation according to the clinical standard
Other: One Day Rehabilitation
Patient discharged at home the day after the operation and carrying out outpatient rehabilitation according to the clinical standard
Active Comparator: Fast Rehabilitation
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKA-L2086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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