Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900181
Status:
UNKNOWN
Last Update Posted:
2021-05-25
First Post:
2021-03-29
Brief Title:
Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty A Pragmatic Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 kgm2 hemoglobin 12gdL 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 11 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 10 g and Tranexamic Acid 04 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None