Arthroplasty, Replacement, Hip, KneeNCT03517098
Enhanced Recovery After Surgery (ERAS) Pathway for Primary Hip and Knee Arthroplasty
A study testing The ERAS group and The non-ERAS group in people with Arthroplasty, Replacement, Hip, Knee, run by West China Hospital at 1 site in China.
Trial summary
As the world goes into the aging society, the number of total hip and total knee arthroplasty (THA and TKA) will increase fast. It's important to develop strategies to improve the quality of healthcare and get earlier recovery and better outcome for patients undergoing THA and TKA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Knee
- What is being tested?
- The ERAS group and The non-ERAS group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary TKA and THA, with both genders.
- Aged more than 18 years.
- Ability to communicate. Exclusion criteria
- Refuse to sign consent.
- Pregnancy or lactating woman
- History or family history of malignant hyperthermia.
Show all 13Show fewer
- Known allergy to desflurane or any other anesthetic agent.
- History of substance abuse.
- History of postoperative delirium.
- Impairment of cognitive function or communication.
- Psychopathy.
- Active participation in another trial where the primary endpoint follow-up is ongoing.
- Unwillingness or inability to comply with protocol procedures.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Surgery (ERAS) Pathway for Primary Hip and Knee Arthroplasty: a Prospective, Controlled, Randomized Clinical Trial
As the world goes into the aging society, the number of total hip and total knee arthroplasty (THA and TKA) will increase fast. It's 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.
Read the 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 0.33 million total hip arthroplasty (THA) and 0.7 million total knee arthroplasty (TKA) were performed in the United States annually, and the demand for the procedures were estimated to 0.57 million and 3.48 million per year in 2030, respectively. It's 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 blood/gas 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, we'll 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.
- Conditions
- Arthroplasty, Replacement, Hip, Knee
- Being tested
- The ERAS group, The non-ERAS group
- Keywords
- Enhanced recovery after surgery, General anesthesia, Total hip arthroplasty, Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ERAS groupProcedure or surgery
ERAS pathway for orthopedic surgeons:
- Shortened preoperative fasting from intake.
- Preoperative tranexamic acid administration.
- No indwelling catheters.
- No tourniquet used for TKA.
- No drainage tube.
- Application of the low molecular heparin 6 hours after the operation.
ERAS pathway for anesthesiologist:
- Intravenous 20 mg of dexamethasone before anesthetic induction.
- Anesthesia will be induced with small dose of long-acting opioids such as sulfentanil, or without long-acting opioids at all.
- Laryngeal mask for airway.
- Anesthesia will be maintained with short-acting anesthetic agents such as desflurane, sevoflurane, or propofol, with continuous remifentanil , and BIS value will be kept between 40 to 60 during procedure.
- Incision infiltration with 40-50ml of 0.2% ropivacaine, and no patient controlled intravenous analgesia devices will be applied.
The non-ERAS groupProcedure or surgery
Patients undergoing THA or TKA will receive conventional care according to different participating center, and there's no standard protocol for pre-operative management, anesthetic technique or medication choice, postoperative analgesia or food intake, or catheters indwelling.
| Study group | Role | What they receive |
|---|---|---|
| The ERAS group | Experimental | Patients will be treated with the ERAS pathway Receives: Procedure: The ERAS group |
| The non-ERAS group | Other | Patients undergoing THA or TKA will receive conventional care. Receives: Procedure: The non-ERAS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay (LOS) in hospital
Time from the day on arrival at hospital to discharge from the hospital (unit: days).
Measured: 30 days
Secondary outcomes (8)
Postoperative LOS
Time from the day of operation to discharge from the hospital (unit: days).
Measured: 30 days
All-cause mortality by 30 days after operation.
All-cause mortality by 30 days after operation.
Measured: 30 days after operation
In-hospital complications
Complications after operation
Measured: 30 days after operation
Mobilization time
Time from the end of operation to ability to walk without human assistance (unit: hours).
Measured: 30 days after operation
Numerical rating scales (NRS) scores at rest and with mobilization or physical therapy
NRS scores will be applied to evaluate the postoperative pain by the patients themselves using a single 11-point numeric rating scale, which is ranged from 0 to 10, where 0 indicates "no pain" and 10 represents "worst imaginable pain".
Measured: 14 days after operation
Postoperative analgesics requirement.
Postoperative sufentanil or other analgesics requirement.
Measured: 7 days after operation
Total in-hospital cost.
All cost during hospitalization
Measured: 30 days
Readmission rate
Readmission rate by 30 days after discharge from the hospital.
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start1 Feb 2021
- Primary completion31 Jan 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, Hip, KneeStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, M.D., Principal investigator, Department of anesthesiology, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517098
- Sponsor's protocol ID
- ERAS180424
- Status last verified
- May 2024
- First submitted
- 24 Apr 2018
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be accessed under request to Dr. Ren Liao by email: liaoren7733@163.com.
Publications
Liao C, Lai X, Zhong J, Zeng W, Zhang J, Deng W, Shu J, Zhong H, Cai L, Liao R. Reducing the length of hospital stay for patients undergoing primary total knee arthroplasty by application of enhanced recovery after surgery (ERAS) pathway: a multicenter, prospective, randomized controlled trial. Eur J Med Res. 2025 May 14;30(1):385. doi: 10.1186/s40001-025-02647-8.
PubMed 40369602Li J, Zhu H, Liao R. Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial. Trials. 2019 Oct 22;20(1):599. doi: 10.1186/s13063-019-3706-8.
PubMed 31640757
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery (ERAS) Pathway for Primary Hip and Knee Arthroplasty: a Prospective, Controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03517098
- Acronym / sponsor ID
- ERAS180424
- Conditions
- Arthroplasty, Replacement, Hip, Knee
- Keywords
- Enhanced recovery after surgery, General anesthesia, Total hip arthroplasty, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As the world goes into the aging society, the number of total hip and total knee arthroplasty (THA and TKA) will increase fast. It's 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.
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 0.33 million total hip arthroplasty (THA) and 0.7 million total knee arthroplasty (TKA) were performed in the United States annually, and the demand for the procedures were estimated to 0.57 million and 3.48 million per year in 2030, respectively. It's 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 blood/gas 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, we'll 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The ERAS group | Experimental | Procedure: The ERAS groupPatients will be treated with the ERAS pathway |
| The non-ERAS group | Other | Procedure: The non-ERAS groupPatients undergoing THA or TKA will receive conventional care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients undergoing primary TKA and THA, with both genders.
- Aged more than 18 years.
- Ability to communicate. Exclusion criteria
- Refuse to sign consent.
- Pregnancy or lactating woman
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The ERAS groupERAS pathway for orthopedic surgeons: 1. Shortened preoperative fasting from intake. 2. Preoperative tranexamic acid administration. 3. No indwelling catheters. 4. No tourniquet used for TKA. 5. No drainage tube. 6. Application of the low molecular heparin 6 hours after the operation. ERAS pathway for anesthesiologist: 1. Intravenous 20 mg of dexamethasone before anesthetic induction. 2. Anesthesia will be induced with small dose of long-acting opioids such as sulfentanil, or without long-acting opioids at all. 3. Laryngeal mask for airway. 4. Anesthesia will be maintained with short-acting anesthetic agents such as desflurane, sevoflurane, or propofol, with continuous remifentanil , and BIS value will be kept between 40 to 60 during procedure. 5. Incision infiltration with 40-50ml of 0.2% ropivacaine, and no patient controlled intravenous analgesia devices will be applied. | Procedure or surgery | The ERAS group |
| The non-ERAS groupPatients undergoing THA or TKA will receive conventional care according to different participating center, and there's no standard protocol for pre-operative management, anesthetic technique or medication choice, postoperative analgesia or food intake, or catheters indwelling. | Procedure or surgery | The non-ERAS group |
Primary outcome
Length of stay (LOS) in hospital
Time frame: 30 days
Time from the day on arrival at hospital to discharge from the hospital (unit: days).
8 secondary outcomes
Postoperative LOS
Time frame: 30 days
All-cause mortality by 30 days after operation.
Time frame: 30 days after operation
In-hospital complications
Time frame: 30 days after operation
Mobilization time
Time frame: 30 days after operation
Numerical rating scales (NRS) scores at rest and with mobilization or physical therapy
Time frame: 14 days after operation
Postoperative analgesics requirement.
Time frame: 7 days after operation
Total in-hospital cost.
Time frame: 30 days
Readmission rate
Time frame: 30 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 40369602Liao C, Lai X, Zhong J, Zeng W, Zhang J, Deng W, Shu J, Zhong H, Cai L, Liao R. Reducing the length of hospital stay for patients undergoing primary total knee arthroplasty by application of enhanced recovery after surgery (ERAS) pathway: a multicenter, prospective, randomized controlled trial. Eur J Med Res. 2025 May 14;30(1):385. doi: 10.1186/s40001-025-02647-8.
- Derived from this study: PubMed 31640757Li J, Zhu H, Liao R. Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial. Trials. 2019 Oct 22;20(1):599. doi: 10.1186/s13063-019-3706-8.
- Individual participant dataSharing planned: Yes. Individual participant data will be accessed under request to Dr. Ren Liao by email: liaoren7733@163.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ren Liao, M.D. principal investigator
Department of anesthesiology, West China Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The ERAS group and The non-ERAS group in people with Arthroplasty, Replacement, Hip, Knee, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (LOS) in hospital (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03517098, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.