Osteoarthritis, KneeFastTrack-GNCT03869996
Total Knee Arthroplasty: Fast Track Protocol is the Future?
A study testing fast track care protocol in people with Osteoarthritis, Knee and Arthropathy of Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Arthropathy of Knee
- What is being tested?
- fast track care protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 25 Feb 2019to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- psychiatric diseases
- preoperative use of crutches
- ASA > 3
- preoperative HB < 13 g/dl
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cesare Stagni, MD contact
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzli
Bologna, 40136
Martina Rocchi, MD, 00393338705057, martina.rocchi@ior.it
Cesare Stagni, MD, cesare.stagni@ior.it
About this study
Official title: Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Arthropathy of Knee
- Being tested
- fast track care protocol, standard care protocol
- Keywords
- fast track care, total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast track care protocolProcedure or surgery
fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.
standard care protocolProcedure or surgery
standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.
| Study group | Role | What they receive |
|---|---|---|
| fast track total knee arthroplasties | Active comparator | patients treated using fast track care protocol Receives: Procedure: fast track care protocol |
| standard care total knee arthroplasties | Active comparator | patients treated using standard care protocol Receives: Procedure: standard care protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Third post operative day
Secondary outcomes (12)
hospital staying
The collection of hospital stay for each patient. The fast track expecting hospital stay is three days.
Measured: Third day after surgery
Incidence of early major complications
The collection of acute infection and early fracture
Measured: Third day after surgery
Number of transfusions
the collection of number of transfusions during hospital staying
Measured: Third day after surgery
Analgesic consumption
The request for analgesic rescue in relation to fast track standard analgesic scheme
Measured: Third day after surgery
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.
Measured: 6 weeks after surgery
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.
Measured: third month after surgery
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.
Measured: sixth month after surgery
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.
Measured: twelfth month after surgery
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.
Measured: 6 weeks after surgery
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.
Measured: third month after surgery
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.
Measured: sixth month after surgery
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.
Measured: twelfth month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start25 Feb 2019
- Primary completion31 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cesare Stagni, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869996
- Sponsor's protocol ID
- 0001094
- Acronym
- FastTrack-G
- Status last verified
- May 2026
- First submitted
- 14 Feb 2019
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03869996
- Acronym / sponsor ID
- FastTrack-G / 0001094
- Conditions
- Osteoarthritis, Knee, Arthropathy of Knee
- Keywords
- fast track care, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fast track total knee arthroplasties | Active comparator | Procedure: fast track care protocolpatients treated using fast track care protocol |
| standard care total knee arthroplasties | Active comparator | Procedure: standard care protocolpatients treated using standard care protocol |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- psychiatric diseases
- preoperative use of crutches
- ASA > 3
- preoperative HB < 13 g/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fast track care protocolfast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol. | Procedure or surgery | fast track total knee arthroplasties |
| standard care protocolstandard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol. | Procedure or surgery | standard care total knee arthroplasties |
Primary outcome
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.
12 secondary outcomes
hospital staying
Time frame: Third day after surgery
Incidence of early major complications
Time frame: Third day after surgery
Number of transfusions
Time frame: Third day after surgery
Analgesic consumption
Time frame: Third day after surgery
Knee Society Score (KSS) at 6 weeks
Time frame: 6 weeks after surgery
Knee Society Score (KSS) at third month
Time frame: third month after surgery
Knee Society Score (KSS) at sixth month
Time frame: sixth month after surgery
Knee Society Score (KSS) at twelfth month
Time frame: twelfth month after surgery
Oxford Score (OS) at 6 weeks
Time frame: 6 weeks after surgery
Oxford Score (OS) at third month
Time frame: third month after surgery
Oxford Score (OS) at sixth month
Time frame: sixth month after surgery
Oxford Score (OS) at twelfth month
Time frame: twelfth month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cesare Stagni, MD contact
Cesare Stagni, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fast track care protocol in people with Osteoarthritis, Knee and Arthropathy of Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Rocchi, MD (00393338705057, martina.rocchi@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early functional outcomes (time frame: Third post operative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.