NCT04145921

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

2.5 years

First QC Date

October 29, 2019

Last Update Submit

October 29, 2019

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (2)

  • post-operative length of hospital stay

    post-operative length of hospital stay

    up to 2 weeks after operation

  • 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 Outcomes (7)

  • post-operative VAS pain scores

    up to 24 hours after operation

  • post-operative analgesics usage

    up to 2 weeks after operation

  • the rate of blood transfusion

    up to 2 weeks after operation

  • rate of PONV

    up to 2 weeks after operation

  • post-operative 1-year Harris hip score

    1 year after operation

  • +2 more secondary outcomes

Study Arms (2)

ERAS for MIS-THA

EXPERIMENTAL

enhanced recovery after surgery (ERAS) pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)

Procedure: ERAS for MIS-THA

conventional MIS-THA

ACTIVE COMPARATOR

conventional pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)

Procedure: conventional MIS-THA

Interventions

ERAS for MIS-THAPROCEDURE

enhanced recovery after surgery (ERAS) pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)

ERAS for MIS-THA
conventional MIS-THAPROCEDURE

conventional pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)

conventional MIS-THA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with renal or hepatic function impairment which precluded multimodal pain control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Chen-Ti Wang, MD,PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2019

First Posted

October 31, 2019

Study Start

January 7, 2014

Primary Completion

June 28, 2016

Study Completion

August 28, 2018

Last Updated

October 31, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share