Fast Track Total Hip Arthroplasty vs Standard Care

NCT04211987 | Completed

• 1 other identifier: 14-19
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis; Hip Pain Chronic

Keywords

fast track care; Total 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 50, where 50 indicates better functional results.

  Third post operative day

Secondary Outcomes (9)

• hospital staying

  Third post operative day

• Harris Hip Score (HHS)

  6 weeks after surgery

• Harris Hip Score (HHS)

  3 months after surgery

• Harris Hip Score (HHS)

  6 months after surgery

• Harris Hip Score (HHS)

  12 months after surgery

Study Arms (2)

Fast track care protocol

ACTIVE COMPARATOR

patients treated using fast track care protocol

Procedure: fast track care protocol

Standard care protocol

ACTIVE COMPARATOR

patients treated using standard care protocol

Procedure: standard care protocol

Interventions

fast track care protocol PROCEDURE

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

Fast track care protocol

standard care protocol PROCEDURE

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

Standard care protocol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by hip osteoarthritis, eligible for primary total hip arthroplasty
• BMI \< 32
• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dante Dallari

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

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: December 23, 2019
• First Posted: December 26, 2019
• Study Start: March 13, 2018
• Primary Completion: December 31, 2020
• Study Completion: January 25, 2021
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

IT (1)