NCT04900181

Brief Summary

Total hip arthroplasty (THA) causes a great medical burden globally, and the same-day discharge (SDD) method has previously been considered to be cost saving. However, a standard cost-effectiveness analysis (CEA) in a randomized controlled trial (RCT) is needed to evaluated the benefits of SDD when performing THA from the perspective of both economic and clinical outcomes. So the objective is to evaluate the cost-effectiveness of SDD for hip replacement. This was a single center, pragmatic RCT with a 6-month follow up. Eighty-four participants who met the inclusion criteria were randomized to either the SDD group or the inpatient group (42 per group). Outcomes were assessed by an independent orthopedist who was not in the surgical team, using the Oxford Hip Score (OHS), EuroQol 5D (EQ-5D) and 36-Item Short-From Health Survey (SF-36) scores at the baseline and the 6-month follow up. All interviews were conducted face to face. All the cost information was collected both from payment receipts and insurance reimbursement records.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

May 25, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

March 29, 2021

Last Update Submit

May 23, 2021

Conditions

Keywords

same-day discharge surgerytotal hip arthropathycost effectiveness

Outcome Measures

Primary Outcomes (1)

  • the Oxford Hip Score

    the Oxford Hip Score consists of 12 questions reflecting the different aspects of hip function. Each question was scored from 0 to 4, with 4 representing the best outcome or least symptoms

    six months

Secondary Outcomes (1)

  • the quality-adjusted life years

    six months

Study Arms (2)

the same-day discharge surgery

EXPERIMENTAL

Patients in the the same-day discharge surgery group were admitted to hospital, operated and discharged within 24 hour

Procedure: the same-day discharge surgery

inpatient surgery

NO INTERVENTION

Patients in inpatient surgery follow routine procedures and do not need to be discharged on the same day.

Interventions

the same-day discharge surgery is the procedure in which the patient is admitted, operated and discharged within 24 hours.

the same-day discharge surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing unilateral primary THA
  • having the ability to understand the relevant treatment process
  • aged between 18 and 75 years
  • a body mass index (BMI) ≤ 40 kg/m2
  • hemoglobin ≥ 12g/dL
  • American Society of Anesthesiologists (ASA) physical status classification of I or II
  • no ongoing infection or blood coagulation disorders

You may not qualify if:

  • with a history of coronary artery disease
  • chronic obstructive pulmonary disease
  • arrhythmias
  • untreated obstructive sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (5)

  • Kurtz SM, Ong KL, Lau E, Bozic KJ. Impact of the economic downturn on total joint replacement demand in the United States: updated projections to 2021. J Bone Joint Surg Am. 2014 Apr 16;96(8):624-30. doi: 10.2106/JBJS.M.00285.

  • Molloy IB, Martin BI, Moschetti WE, Jevsevar DS. Effects of the Length of Stay on the Cost of Total Knee and Total Hip Arthroplasty from 2002 to 2013. J Bone Joint Surg Am. 2017 Mar 1;99(5):402-407. doi: 10.2106/JBJS.16.00019.

  • Navathe AS, Troxel AB, Liao JM, Nan N, Zhu J, Zhong W, Emanuel EJ. Cost of Joint Replacement Using Bundled Payment Models. JAMA Intern Med. 2017 Feb 1;177(2):214-222. doi: 10.1001/jamainternmed.2016.8263.

  • Doran JP, Zabinski SJ. Bundled payment initiatives for Medicare and non-Medicare total joint arthroplasty patients at a community hospital: bundles in the real world. J Arthroplasty. 2015 Mar;30(3):353-5. doi: 10.1016/j.arth.2015.01.035. Epub 2015 Jan 23.

  • Zeng JQ. The pilot results of 47 148 cases of BJ-DRGs-based payment in China. Int J Health Plann Manage. 2019 Oct;34(4):1386-1398. doi: 10.1002/hpm.2818. Epub 2019 Jul 8.

Related Links

Study Officials

  • Hongtao Tian, doctor

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY DIRECTOR

Central Study Contacts

Hongtao Tian, doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

May 25, 2021

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 15, 2021

Last Updated

May 25, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations