Total Hip Arthroplasty Clinical Trial
Official title:
Effectiveness of Fast-track Clinical Pathway on Minimally-invasive Total Hip Arthroplasty Surgery in NTUH
Verified date | October 2019 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | August 28, 2018 |
Est. primary completion date | June 28, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | post-operative length of hospital stay | post-operative length of hospital stay | up to 2 weeks after operation | |
Primary | rate of same-day independent mobilization | rate of same-day independent mobilization (ambulation without assistance from another person within 24 hours after operation) | up to 24 hours after operation | |
Secondary | post-operative VAS pain scores | post-operative visual analog scale (VAS) pain scores | up to 24 hours after operation | |
Secondary | post-operative analgesics usage | post-operative analgesics usage | up to 2 weeks after operation | |
Secondary | the rate of blood transfusion | the rate of blood transfusion | up to 2 weeks after operation | |
Secondary | rate of PONV | rate of post-operative nausea and vomiting (PONV) | up to 2 weeks after operation | |
Secondary | post-operative 1-year Harris hip score | post-operative 1-year Harris hip score | 1 year after operation | |
Secondary | post-operative 1-year Oxford hip score | post-operative 1-year Oxford hip score | 1 year after operation | |
Secondary | post-operative 1-year EQ-5D index of quality of life | post-operative 1-year EQ-5D index of self-reported health-related quality of life | 1 year after operation |
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