Total Hip Arthroplasty: Fast Track Protocol is the Future?

NCT ID: NCT03875976

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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The aim of this protocol is to compare standard care and fast track total hip 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

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Hip Osteoarthritis Arthropathy of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Fast Track Protocol

Patients treated using Fast Track Care Protocol

Group Type ACTIVE_COMPARATOR

Fast Track Protocol

Intervention Type PROCEDURE

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

Standard Protocol

Patients treated using Standard Care Protocol

Group Type ACTIVE_COMPARATOR

Standard Care Protocol

Intervention Type PROCEDURE

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

Interventions

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Fast Track Protocol

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

Intervention Type PROCEDURE

Standard Care Protocol

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* psychiatric diseases
* preoperative use of crutches
* ASA \> 3
* preoperative HB \< 13 g/dl
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Dante Dallari, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dante Dallari, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

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Istituto Ortopedico Rizzoli

Bologna, Italia, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 34001185 (View on PubMed)

Other Identifiers

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11269

Identifier Type: -

Identifier Source: org_study_id

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