Total Knee Arthroplasty: Fast Track Protocol is the Future?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-78
SponsorIstituto Ortopedico Rizzoli
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
psychiatric diseases
preoperative use of crutches
ASA > 3
preoperative HB < 13 g/dl
Trial design
Design model
Parallel
Treatments tested in this trial
fast track care protocol
Procedure/Surgeryfast 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/Surgerystandard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: fast track total knee arthroplastiesActive comparator 1 intervention
Group B: standard care total knee arthroplastiesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Third post operative daySecondary outcomes
1
hospital staying
The collection of hospital stay for each patient. The fast track expecting hospital stay is three days.
Time frame
Third day after surgery2
Incidence of early major complications
The collection of acute infection and early fracture
Time frame
Third day after surgery3
Number of transfusions
the collection of number of transfusions during hospital staying
Time frame
Third day after surgery4
Analgesic consumption
The request for analgesic rescue in relation to fast track standard analgesic scheme
Time frame
Third day after surgerySponsors and contacts
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Source ClinicalTrials.gov