Effectiveness of Fast-track Clinical Pathway on Minimally-invasive Total Hip Arthroplasty Surgery in NTUH
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Primary Endpoint
- post-operative length of hospital stay
Study Overview
Brief Summary
The objective of this study was to evaluate the effects of an enhanced recovery after surgery (ERAS) pathway incorporated with pre-operative physical therapy and education on immediate and short-term outcomes of minimally-invasive surgery of total hip arthroplasty (MIS-THA). We hypothesized that this ERAS pathway can shorten post-operative length of hospital stay and ensure same-day independent mobilization in MIS-THA. The first specific aim was to compare primary immediate outcomes, including post-operative length of hospital stay and the rate of same-day independent mobilization, between ERAS for MIS-THA patients and conventional MIS-THA patients. The second aim was to compare other immediate outcomes, including post-operative pain scores, analgesics usage, the rate of blood transfusion and post-operative nausea and vomiting (PONV), between the two groups of patients. Third, we aimed to compare short-term outcomes, including post-operative 1-year Harris hip score, Oxford hip score and EQ-5D index of quality of life, between the two groups of patients. We also compared hospital cost and profit between the two groups of patients. Moreover, we identified the factors affecting post-operative length of hospital stay in ERAS for MIS-THA patients.
Detailed Description
Study subjects:
We conducted a prospective comparative study to investigate 50 patients receiving an ERAS pathway incorporated with pre-operative physical therapy and education for MIS-THA and 25 patients receiving conventional MIS-THA. We included the patients with advanced osteonecrosis of femoral head or hip osteoarthritis receiving unilateral primary MIS-THA performed by the same surgeon at the same hospital. We excluded patients with renal or hepatic function impairment which precluded multimodal pain control. However, we did not preselect patients with younger age or better activity level. This study was approved by the Institutional Review Board at National Taiwan University Hospital. Written informed consent was obtained from all patients.
ERAS for MIS-THA versus conventional MIS-THA:
In this study, ERAS for MIS-THA was defined as the ERAS pathway incorporated with pre-operative short-term physical therapy and education for MIS-THA. On the other hand, conventional MIS-THA in this study was defined as the conventional pathway without pre-operative physical therapy and education for MIS-THA. Both of ERAS for MIS-THA and conventional MIS-THA comprised the same MIS-THA techniques, multimodal pain control, standardized volume management and PONV prophylaxis, deep vein thrombosis prophylaxis and post-operative rehabilitation program.
Pre-operative physical therapy and education:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with advanced osteonecrosis of femoral head or hip osteoarthritis receiving unilateral primary minimally-invasive surgery of total hip arthroplasty (MIS-THA) performed by the same surgeon at the same hospital
Exclusion Criteria
- •patients with renal or hepatic function impairment which precluded multimodal pain control
Arms & Interventions
ERAS for MIS-THA
enhanced recovery after surgery (ERAS) pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)
Intervention: ERAS for MIS-THA (Procedure)
conventional MIS-THA
conventional pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)
Intervention: conventional MIS-THA (Procedure)
Outcomes
Primary Outcomes
post-operative length of hospital stay
Time Frame: up to 2 weeks after operation
post-operative length of hospital stay
rate of same-day independent mobilization
Time Frame: up to 24 hours after operation
rate of same-day independent mobilization (ambulation without assistance from another person within 24 hours after operation)
Secondary Outcomes
- rate of PONV(up to 2 weeks after operation)
- post-operative analgesics usage(up to 2 weeks after operation)
- post-operative 1-year EQ-5D index of quality of life(1 year after operation)
- the rate of blood transfusion(up to 2 weeks after operation)
- post-operative VAS pain scores(up to 24 hours after operation)
- post-operative 1-year Harris hip score(1 year after operation)
- post-operative 1-year Oxford hip score(1 year after operation)