NCT03869996

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

6.7 years

First QC Date

February 14, 2019

Last Update Submit

January 15, 2025

Conditions

Osteoarthritis, KneeArthropathy of Knee

Keywords

fast track caretotal knee arthroplasty

Outcome Measures

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.

    Third post operative day

Secondary Outcomes (12)

  • hospital staying

    Third day after surgery

  • Incidence of early major complications

    Third day after surgery

  • Number of transfusions

    Third day after surgery

  • Analgesic consumption

    Third day after surgery

  • Knee Society Score (KSS) at 6 weeks

    6 weeks after surgery

  • +7 more secondary outcomes

Study Arms (2)

fast track total knee arthroplasties

ACTIVE COMPARATOR

patients treated using fast track care protocol

Procedure: fast track care protocol

standard care total knee arthroplasties

ACTIVE COMPARATOR

patients treated using standard care protocol

Procedure: standard care protocol

Interventions

fast track care protocolPROCEDURE

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

fast track total knee arthroplasties
standard care protocolPROCEDURE

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

standard care total knee arthroplasties

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • psychiatric diseases
  • preoperative use of crutches
  • ASA \> 3
  • preoperative HB \< 13 g/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Cesare Stagni, MD

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Rocchi, MD

CONTACT

00393338705057martina.rocchi@ior.it

Cesare Stagni, MD

CONTACT

cesare.stagni@ior.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

March 11, 2019

Study Start

February 25, 2019

Primary Completion

October 31, 2025

Study Completion

November 1, 2025

Last Updated

January 16, 2025

Record last verified: 2025-01

Locations

IT(1)