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NCT Number: NCT03869996

Total Knee Arthroplasty: Fast Track Protocol is the Future?

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Arthropathy of Knee Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fast track care protocol

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 protocol

Procedure

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

Primary outcomes

  1. Early functional outcomes

    Time frame: Third post operative day

    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 outcomes

  1. hospital staying

    Time frame: Third day after surgery

    The collection of hospital stay for each patient. The fast track expecting hospital stay is three days.

  2. Incidence of early major complications

    Time frame: Third day after surgery

    The collection of acute infection and early fracture

  3. Number of transfusions

    Time frame: Third day after surgery

    the collection of number of transfusions during hospital staying

  4. Analgesic consumption

    Time frame: Third day after surgery

    The request for analgesic rescue in relation to fast track standard analgesic scheme

  5. Knee Society Score (KSS) at 6 weeks

    Time frame: 6 weeks after surgery

    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.

  6. Knee Society Score (KSS) at third month

    Time frame: third month after surgery

    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.

  7. Knee Society Score (KSS) at sixth month

    Time frame: sixth month after surgery

    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.

  8. Knee Society Score (KSS) at twelfth month

    Time frame: twelfth month after surgery

    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.

  9. Oxford Score (OS) at 6 weeks

    Time frame: 6 weeks after surgery

    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.

  10. Oxford Score (OS) at third month

    Time frame: third month after surgery

    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.

  11. Oxford Score (OS) at sixth month

    Time frame: sixth month after surgery

    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.

  12. Oxford Score (OS) at twelfth month

    Time frame: twelfth month after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cesare Stagni, MD

CONTACT

[email protected]

Martina Rocchi, MD

CONTACT

[email protected]

00393338705057

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty

Acronym: FastTrack-G

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2019
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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