Clinical trial NCT04211987: Fast Track Total Hip Arthroplasty vs Standard Care
Official title: Evaluation of Functional Rehabilitation Fast Track Total Hip Arthroplasty vs Standard Care: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Hip Pain Chronic
Keywords: fast track care
Total Hip Arthroplasty
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Early functional outcomes
timeFrame: Third post operative day
Secondary outcomes:
measure: hospital staying
timeFrame: Third post operative day
measure: Harris Hip Score (HHS)
timeFrame: 6 weeks after surgery
measure: Harris Hip Score (HHS)
timeFrame: 3 months after surgery
measure: Harris Hip Score (HHS)
timeFrame: 6 months after surgery
measure: Harris Hip Score (HHS)
timeFrame: 12 months after surgery
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 weeks after surgery
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 3 months after surgery
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 months after surgery
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Dante Dallari
role: PRINCIPAL_INVESTIGATOR
References: