Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty
Primary Purpose
Hip Arthropathy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the same-day discharge surgery
Sponsored by
About this trial
This is an interventional treatment trial for Hip Arthropathy focused on measuring same-day discharge surgery, total hip arthropathy, cost effectiveness
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- with a history of coronary artery disease
- chronic obstructive pulmonary disease
- arrhythmias
- untreated obstructive sleep apnea
Sites / Locations
- Wuhan Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
the same-day discharge surgery
inpatient surgery
Arm Description
Patients in the the same-day discharge surgery group were admitted to hospital, operated and discharged within 24 hour
Patients in inpatient surgery follow routine procedures and do not need to be discharged on the same day.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
the quality-adjusted life years
the quality-adjusted life years was calculated as the outcome in cost utility analysis, as proposed by the CHEERS and CEA guidelines. The values of QALYs were estimated by EQ-5D . The EQ-5D was administered at baseline and at the 6-month follow-up. The EQ-5D is divided into five aspects (mobility, self-care, usual activities, discomfort, depression) to evaluate patients' health state, and each consists of three levels. The score for the EQ-5D ranges from -0.59 to 1.00, with a higher score indicating a better quality of life.
Full Information
NCT ID
NCT04900181
First Posted
March 29, 2021
Last Updated
May 23, 2021
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT04900181
Brief Title
Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty
Official Title
Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty: A Pragmatic Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
This was a prospective RCT. Patients qualified for inclusion in the study if they met the following criteria: 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; and no ongoing infection or blood coagulation disorders. Those with a history of coronary artery disease, chronic obstructive pulmonary disease, arrhythmias, or untreated obstructive sleep apnea were excluded. Eligible individuals who gave informed consent were randomly assigned (1:1) to an inpatient THA group or an SDD THA group. SDD-THA was defined as admission, surgery, and discharge within 24 hours, whereas the inpatients stayed in hospital for more than one day. Randomization occurred at the individual level and was performed by an independent statistician, utilizing an automatic computer-generated table of random numbers. Preoperatively, patients undergoing SDD-THA and their families received information in the form of teaching booklets and a teaching class conducted by a bedside clinician, which included the protocol, matters needing attention, exercise training, and home-based rehabilitation. All operations were performed by the same surgical team through a posterolateral approach. Standardized general anesthesia was administered by low-dose bupivacaine, to allow early postoperative patient mobilization. Celebrex 400 mg PO was used as routine analgesia before surgery. Cefazolin (1.0 g) and Tranexamic Acid (0.4 g) were administered 30 min prior to skin incision. A uniform perioperative multimodal pain management protocol was established by cocktail periarticular injection before wound closure, which consisted of Flurbiprofen axetil (50 mg) and Ropivacaine (200 mg). Patients in both groups accepted the same postoperative protocols. To avoid venous thromboembolism (VTE), all participants were encouraged to perform ankle pumping and quadriceps-setting exercises immediately. Additionally, patients were encouraged to get out of bed and ambulate progressively with assistance under the guidance of the bedside clinician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy
Keywords
same-day discharge surgery, total hip arthropathy, cost effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the same-day discharge surgery
Arm Type
Experimental
Arm Description
Patients in the the same-day discharge surgery group were admitted to hospital, operated and discharged within 24 hour
Arm Title
inpatient surgery
Arm Type
No Intervention
Arm Description
Patients in inpatient surgery follow routine procedures and do not need to be discharged on the same day.
Intervention Type
Procedure
Intervention Name(s)
the same-day discharge surgery
Intervention Description
the same-day discharge surgery is the procedure in which the patient is admitted, operated and discharged within 24 hours.
Primary Outcome Measure Information:
Title
the Oxford Hip Score
Description
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
Time Frame
six months
Secondary Outcome Measure Information:
Title
the quality-adjusted life years
Description
the quality-adjusted life years was calculated as the outcome in cost utility analysis, as proposed by the CHEERS and CEA guidelines. The values of QALYs were estimated by EQ-5D . The EQ-5D was administered at baseline and at the 6-month follow-up. The EQ-5D is divided into five aspects (mobility, self-care, usual activities, discomfort, depression) to evaluate patients' health state, and each consists of three levels. The score for the EQ-5D ranges from -0.59 to 1.00, with a higher score indicating a better quality of life.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
with a history of coronary artery disease
chronic obstructive pulmonary disease
arrhythmias
untreated obstructive sleep apnea
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongtao Tian, doctor
Phone
18627171618
Email
tianhongtao@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongtao Tian, doctor
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Director
Facility Information:
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongtao Tian, doctor
Phone
18627171618
Email
tianhongtao@vip.163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24740658
Citation
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.
Results Reference
result
PubMed Identifier
28244911
Citation
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.
Results Reference
result
PubMed Identifier
28055062
Citation
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.
Results Reference
result
PubMed Identifier
25680450
Citation
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.
Results Reference
result
PubMed Identifier
31286577
Citation
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.
Results Reference
result
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/
Description
The link of citation
Learn more about this trial
Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty
We'll reach out to this number within 24 hrs