Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty

Hip Arthropathy Clinical Trial

Official title:

Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty: A Pragmatic Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900181
• Other study ID #: 271816
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: April 2021
• Source: Wuhan Union Hospital, China
• Contact: Hongtao Tian, doctor
• Phone: 18627171618
• Email: tianhongtao[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 15, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

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

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	six months

External Links

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