Ignite Creation Date:
2024-05-06 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03517098
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2018-04-24
Brief Title:
Enhanced Recovery After Surgery ERAS Pathway for Primary Hip and Knee Arthroplasty
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Enhanced Recovery After Surgery ERAS Pathway for Primary Hip and Knee Arthroplasty a Prospective Controlled Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-05
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:
As the world goes into the aging society the number of total hip and total knee arthroplasty THA and TKA will increase fast Its important to develop strategies to improve the quality of healthcare and get earlier recovery and better outcome for patients undergoing THA and TKA Enhanced recovery after surgery ERAS pathways have been reported to promote faster recovery in some clinical settings but most of them are retrospective cohort study We hypothesized that ERAS pathway could provide better recovery than current routine clinical practice for patients undergoing primary THA or TKA
This trial is a prospective open-labelled randomized controlled trial that will test for length of stay LOS in hospital the superiority of ERAS pathway as compared with current clinical practice A total of 604 patients undergoing primary THA or TKA will be randomized to allocate either ERAS pathway ERAS group or conventional care according to different participating center non-ERAS group The primary outcome is LOS in hospital Secondary outcomes include Postoperative LOS all-cause mortality by 30 days after operation in-hospital complications mobilization postoperative pain evaluation total in-hospital cost and readmission rate by 30 days after discharge from the hospital
This trial is a prospective open-labelled randomized controlled trial that will test for length of stay LOS in hospital the superiority of ERAS pathway as compared with current clinical practice A total of 604 patients undergoing primary THA or TKA will be randomized to allocate either ERAS pathway ERAS group or conventional care according to different participating center non-ERAS group The primary outcome is LOS in hospital Secondary outcomes include Postoperative LOS all-cause mortality by 30 days after operation in-hospital complications mobilization postoperative pain evaluation total in-hospital cost and readmission rate by 30 days after discharge from the hospital
Detailed Description:
Total joint arthroplasty is a definitive treatment for end-stage osteoarthritis of the hip and knee which is increased as the world goes into the aging society It was reported that 033 million total hip arthroplasty THA and 07 million total knee arthroplasty TKA were performed in the United States annually and the demand for the procedures were estimated to 057 million and 348 million per year in 2030 respectively Its important to find strategies to improve the quality of healthcare and get earlier recovery and better outcome for patients undergoing THA and TKA so as to slow the growth of the heavy economic burden associated with the increase of the procedures
Enhanced recovery after surgery ERAS is proposed as a series of evidence-based perioperative optimization with multidisciplinary treatment to reduce surgical stress and accelerate postoperative recovery Under this general guidelines different ERAS pathways have been reported to decrease morbidity save costs promote faster recovery and achieve the clinical and economic gain in colorectal thoracic and orthopedic surgery Regional anesthesia was recommended for ERAS because it provides reliable analgesia and little disturbance on hemodynamics in previous literatures But for patients undergoing THA and TKA epidural or spinal anesthesia is always associated with indwelling urinary catheter even in surgery with short duration and small amount of blood loss and femoral or sciatic nerve block decreases muscle strength leading to postponed mobilization Nowadays anesthetic agents with rapid onsetting and clearance make ERAS be applied under general anesthesia For example desflurane a volatile anesthetic with a low bloodgas distribution coefficient has been reported to metabolized quickly with minor dependence on liver and kidney function and provide rapid awakening from anesthetic state Based on its characteristics we hypothesized that ERAS could be achieved by general anesthesia with the use of short-acting anesthetic agents with the combination of short-acting opioids and muscle relaxant
In this trial well develop ERAS pathway in patients undergoing primary THA and TKA and compare with the conventional treatment in length of stay LOS in hospital postoperative complications as well as the hospitalization costs The aim of this trial is to verify our hypothesis that ERAS could provide reduced LOS while not increase complications and in-hospital cost when compared with the current clinical practice
Enhanced recovery after surgery ERAS is proposed as a series of evidence-based perioperative optimization with multidisciplinary treatment to reduce surgical stress and accelerate postoperative recovery Under this general guidelines different ERAS pathways have been reported to decrease morbidity save costs promote faster recovery and achieve the clinical and economic gain in colorectal thoracic and orthopedic surgery Regional anesthesia was recommended for ERAS because it provides reliable analgesia and little disturbance on hemodynamics in previous literatures But for patients undergoing THA and TKA epidural or spinal anesthesia is always associated with indwelling urinary catheter even in surgery with short duration and small amount of blood loss and femoral or sciatic nerve block decreases muscle strength leading to postponed mobilization Nowadays anesthetic agents with rapid onsetting and clearance make ERAS be applied under general anesthesia For example desflurane a volatile anesthetic with a low bloodgas distribution coefficient has been reported to metabolized quickly with minor dependence on liver and kidney function and provide rapid awakening from anesthetic state Based on its characteristics we hypothesized that ERAS could be achieved by general anesthesia with the use of short-acting anesthetic agents with the combination of short-acting opioids and muscle relaxant
In this trial well develop ERAS pathway in patients undergoing primary THA and TKA and compare with the conventional treatment in length of stay LOS in hospital postoperative complications as well as the hospitalization costs The aim of this trial is to verify our hypothesis that ERAS could provide reduced LOS while not increase complications and in-hospital cost when compared with the current clinical practice
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