Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty
- Conditions
- Hip Arthropathy
- Interventions
- Procedure: the same-day discharge surgery
- Registration Number
- NCT04900181
- Lead Sponsor
- Wuhan Union Hospital, China
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
- 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
- with a history of coronary artery disease
- chronic obstructive pulmonary disease
- arrhythmias
- untreated obstructive sleep apnea
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the same-day discharge surgery the same-day discharge surgery Patients in the the same-day discharge surgery group were admitted to hospital, operated and discharged within 24 hour
- Primary Outcome Measures
Name Time Method the Oxford Hip Score six months 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
Name Time Method the quality-adjusted life years six months 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.
Trial Locations
- Locations (1)
Wuhan Union Hospital
🇨🇳Wuhan, Hubei, China