NCT03875976

Brief Summary

Fast-track total hip arthroplasty (THA) 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 hip arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

March 13, 2019

Last Update Submit

July 20, 2023

Conditions

Hip OsteoarthritisArthropathy of Hip

Keywords

fast track caretotal hip 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 56, where 56 indicates worst functional results.

    Third post operative day

Secondary Outcomes (12)

  • hospital staying

    Third post operative day

  • Incidence of early major complications

    Third day after surgery

  • Number of transfusions

    Third day after surgery

  • Analgesic consumption

    Third day after surgery

  • Harris Hip Score (HHS) at 6 weeks

    6 weeks after surgery

  • +7 more secondary outcomes

Study Arms (2)

Fast Track Protocol

ACTIVE COMPARATOR

Patients treated using Fast Track Care Protocol

Procedure: Fast Track Protocol

Standard Protocol

ACTIVE COMPARATOR

Patients treated using Standard Care Protocol

Procedure: Standard Care Protocol

Interventions

Fast Track ProtocolPROCEDURE

Fast Track Care consists in educational preoperative preparation for patients, particular strategies for controlling pain and intensive early rehabilitation protocol

Fast Track Protocol
Standard Care ProtocolPROCEDURE

Standard Care Protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol

Standard Protocol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients affected by hip osteoarthritis, eligible for primary total hip 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 Rizzoli

Bologna, Italia, 40136, Italy

Location

Related Publications (1)

  • Rocchi M, Stagni C, Govoni M, Mazzotta A, Vivarelli L, Orlandi Magli A, Perrone M, Benedetti MG, Dallari D. Comparison of a fast track protocol and standard care after hip arthroplasty in the reduction of the length of stay and the early weight-bearing resumption: study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):348. doi: 10.1186/s13063-021-05314-5.

    PMID: 34001185DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Dante Dallari, MD

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study aims to evaluate the effectiveness of a fast track protocol , which consists of an innovative analgesic therapy scheme and a rapid rehabilitation protocol, and a standard care protocol.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 15, 2019

Study Start

March 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2023

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share
Shared Documents
ICF

Locations

IT(1)