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

NCT ID: NCT06302075

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Gonarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One Day Rehabilitation

discharged home the day after the operation (24 hours) and carrying out outpatient rehabilitation according to the clinical standard

Group Type EXPERIMENTAL

One Day Rehabilitation

Intervention Type OTHER

Patient discharged at home the day after the operation and carrying out outpatient rehabilitation according to the clinical standard

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

Group Type ACTIVE_COMPARATOR

Fast Rehabilitation

Intervention Type OTHER

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

Interventions

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One Day Rehabilitation

Patient discharged at home the day after the operation and carrying out outpatient rehabilitation according to the clinical standard

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Clinico San Siro

Milan, Italia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elena Cittera

Role: CONTACT

Facility Contacts

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Elena Cittera

Role: primary

0283502224

Other Identifiers

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UKA-L2086

Identifier Type: -

Identifier Source: org_study_id

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