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Total Knee Arthroplasty: Fast Track Protocol is the Future? (FastTrack-G)

Primary Purpose

Osteoarthritis, Knee, Arthropathy of Knee

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
fast track care protocol
standard care protocol
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring fast track care, total knee arthroplasty

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istituto Ortopedico RizzliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

fast track total knee arthroplasties

standard care total knee arthroplasties

Arm Description

patients treated using fast track care protocol

patients treated using standard care protocol

Outcomes

Primary Outcome Measures

Early functional outcomes
Early functional outcomes are collecting using Lowa Level of Assistance(ILOA) during the third post-operative day. This scale is able to provide data on the autonomy reached by the patient in the first postoperative period going to investigate five main motor activities (get up from supine to seated, from sitting to standing position, walk around, take three steps, the speed of walking). the total score can vary from 0 to 50, where 50 indicates better functional results.

Secondary Outcome Measures

hospital staying
The collection of hospital stay for each patient. The fast track expecting hospital stay is three days.
Incidence of early major complications
The collection of acute infection and early fracture
Number of transfusions
the collection of number of transfusions during hospital staying
Analgesic consumption
The request for analgesic rescue in relation to fast track standard analgesic scheme
Knee Society Score (KSS) at 6 weeks
The collection of functional outcomes score KSS at 6 weeks. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.
Knee Society Score (KSS) at third month
The collection of functional outcomes score KSS at third month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.
Knee Society Score (KSS) at sixth month
The collection of functional outcomes score KSS at sixth month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.
Knee Society Score (KSS) at twelfth month
The collection of functional outcomes score KSS at twelfth month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.
Oxford Score (OS) at 6 weeks
The collection of functional outcomes score OS at 6 weeks. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Oxford Score (OS) at third month
The collection of functional outcomes score OS at third month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Oxford Score (OS) at sixth month
The collection of functional outcomes score OS at sixth month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Oxford Score (OS) at twelfth month
The collection of functional outcomes score OS at twelfth month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.

Full Information

First Posted
February 14, 2019
Last Updated
July 20, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT03869996
Brief Title
Total Knee Arthroplasty: Fast Track Protocol is the Future?
Acronym
FastTrack-G
Official Title
Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Arthropathy of Knee
Keywords
fast track care, total knee arthroplasty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fast track total knee arthroplasties
Arm Type
Active Comparator
Arm Description
patients treated using fast track care protocol
Arm Title
standard care total knee arthroplasties
Arm Type
Active Comparator
Arm Description
patients treated using standard care protocol
Intervention Type
Procedure
Intervention Name(s)
fast track care protocol
Intervention Description
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
Intervention Name(s)
standard care protocol
Intervention Description
standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.
Primary Outcome Measure Information:
Title
Early functional outcomes
Description
Early functional outcomes are collecting using Lowa Level of Assistance(ILOA) during the third post-operative day. This scale is able to provide data on the autonomy reached by the patient in the first postoperative period going to investigate five main motor activities (get up from supine to seated, from sitting to standing position, walk around, take three steps, the speed of walking). the total score can vary from 0 to 50, where 50 indicates better functional results.
Time Frame
Third post operative day
Secondary Outcome Measure Information:
Title
hospital staying
Description
The collection of hospital stay for each patient. The fast track expecting hospital stay is three days.
Time Frame
Third day after surgery
Title
Incidence of early major complications
Description
The collection of acute infection and early fracture
Time Frame
Third day after surgery
Title
Number of transfusions
Description
the collection of number of transfusions during hospital staying
Time Frame
Third day after surgery
Title
Analgesic consumption
Description
The request for analgesic rescue in relation to fast track standard analgesic scheme
Time Frame
Third day after surgery
Title
Knee Society Score (KSS) at 6 weeks
Description
The collection of functional outcomes score KSS at 6 weeks. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.
Time Frame
6 weeks after surgery
Title
Knee Society Score (KSS) at third month
Description
The collection of functional outcomes score KSS at third month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.
Time Frame
third month after surgery
Title
Knee Society Score (KSS) at sixth month
Description
The collection of functional outcomes score KSS at sixth month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.
Time Frame
sixth month after surgery
Title
Knee Society Score (KSS) at twelfth month
Description
The collection of functional outcomes score KSS at twelfth month. The Knee Society Score (KSS) is mixed outcome measure that's both objective (physician input) and subjective (patient input). A score between 80 and 100 is considered excellent, between 70 and 79 is considered good, between 60 and 69 is considered fair and below 60 is considered poor.
Time Frame
twelfth month after surgery
Title
Oxford Score (OS) at 6 weeks
Description
The collection of functional outcomes score OS at 6 weeks. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Time Frame
6 weeks after surgery
Title
Oxford Score (OS) at third month
Description
The collection of functional outcomes score OS at third month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Time Frame
third month after surgery
Title
Oxford Score (OS) at sixth month
Description
The collection of functional outcomes score OS at sixth month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Time Frame
sixth month after surgery
Title
Oxford Score (OS) at twelfth month
Description
The collection of functional outcomes score OS at twelfth month. The Oxford Score is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement surgery. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Time Frame
twelfth month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Rocchi, MD
Phone
00393338705057
Email
martina.rocchi@ior.it
First Name & Middle Initial & Last Name or Official Title & Degree
Cesare Stagni, MD
Email
cesare.stagni@ior.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Stagni, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Rocchi, MD
Phone
00393338705057
Email
martina.rocchi@ior.it
First Name & Middle Initial & Last Name & Degree
Cesare Stagni, MD
Email
cesare.stagni@ior.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Total Knee Arthroplasty: Fast Track Protocol is the Future?

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