Total Knee Arthroplasty: Fast Track Protocol is the Future?

NCT ID: NCT03869996

Last Updated: 2025-01-16

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2025-11-01

Brief Summary

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Fast-track total knee arthroplasty (TKA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total knee arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

Detailed Description

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The aim of this protocol is to compare standard care and fast track total knee arthroplasties. The fast track care consists of:

* preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients
* antalgic protocol administered only orally
* early rehabilitation care. The day of the surgical operation, the physiotherapist helps the patient reach the upright position.

The standard care consists of usual antalgic and physiotherapy post-operative care:

* Antalgic protocol consist in intravenous drugs
* the first physiotherapy session is the day after surgery.

Conditions

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Osteoarthritis, Knee Arthropathy of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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fast track total knee arthroplasties

patients treated using fast track care protocol

Group Type ACTIVE_COMPARATOR

fast track care protocol

Intervention Type PROCEDURE

fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.

standard care total knee arthroplasties

patients treated using standard care protocol

Group Type ACTIVE_COMPARATOR

standard care protocol

Intervention Type PROCEDURE

standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.

Interventions

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fast track care protocol

fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.

Intervention Type PROCEDURE

standard care protocol

standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty
* BMI \< 32
* Time up ang go test \</= 12 seconds
* American Society of Anesthesiologists physical status classification system (ASA) \</= 2
* preoperative hemoglobin (HB) \>13 g/dl
* patients eligible for spinal anesthesia
* presence of a care-giver

Exclusion Criteria

* psychiatric diseases
* preoperative use of crutches
* ASA \> 3
* preoperative HB \< 13 g/dl
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cesare Stagni, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

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Istituto Ortopedico Rizzli

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Martina Rocchi, MD

Role: CONTACT

00393338705057

Cesare Stagni, MD

Role: CONTACT

Facility Contacts

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Martina Rocchi, MD

Role: primary

00393338705057

Cesare Stagni, MD

Role: backup

Other Identifiers

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0001094

Identifier Type: -

Identifier Source: org_study_id

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