Arthroplasty, Replacement, Knee, HipNCT03869203
Prospective Randomized Controlled Trial of Impact of Enhanced Recovery After Surgery(ERAS) for Outcomes of Total Knee and Hip Arthroplasty
A study testing Enhanced recovery after surgery (ERAS) in people with Arthroplasty, Replacement, Knee, Hip, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to analyze the effect of the ERAS(early recovery after surgery) protocol on total knee and hip arthroplasty compared to conventional standard protocol. Patients will be divided into two groups: ERAS protocol group and standard protocol group. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Hip
- What is being tested?
- Enhanced recovery after surgery (ERAS)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2019to Sep 2020
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. elective total knee arthroplasty for degenerative osteoarthritis
- 2. elective total hip arthroplasty for osteoarthritis of osteonecrosis of femoral head
Who cannot join
- 1. ASA class >3
- 2. severe medical comorbidities
- 3. inflammatory arthritis including rheumatoid arthritis
- 4. severe instability of knee or hip
- 5. revision surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Orthopedic Surgery, Yonsei University, College of Medicine
Seoul
Kwan Kyu Park, PhD, 82-2-2228-2180, kkpark@yuhs.ac
About this study
The purpose of this study is to analyze the effect of the ERAS(early recovery after surgery) protocol on total knee and hip arthroplasty compared to conventional standard protocol. Patients will be divided into two groups: ERAS protocol group and standard protocol group. On the day before the surgery, the patient group was randomly assigned by the researcher (research nurse) who did not participate in the surgical procedure. By comparing the clinical outcomes and quality of postoperative recovery of both groups, we could confirm the effect of ERAS protocol.
Read the detailed description
The patients who underwent radiologic examination at Severance Hospital of Severance Hospital and who will received total knee arthroplasty or total hip arthroplasty due to primary degenerative osteoarthritis or osteonecrosis of femoral head. Patients will be divided into two groups: ERAS (early recovery after surgery) protocol group and standard protocol group. On the day before the surgery, the patient group was randomly assigned by the researcher (research nurse) who did not participate in the surgical procedure.
The patients in the ERAS group were given a pre-treatment drug [300 mg (gabapentin) and 10 mg oxycontin (oxycontin) and 2 mg prednisolone (prednisolone 10 mg)] on the evening before surgery. And pre-operative fasting should not exceed 6 hours, and clear liquid fasting should not exceed 2 hours. In addition, 400 ml of oral carbohydrate should be taken 2 to 4 hours before surgery to ensure adequate blood sugar and encourage regular diet (light meal) as soon as possible within a tolerable range after surgery. The initial pain after surgery is actively controlled by oral drugs such as celebrex and IR codon, and injections such as tramadol and demerol. On the first postoperative day, the urinary catheter is removed and CPM (continuous passive motion) rehabilitation is started.
On the other hand, in standard group, there is no medication as a pre-treatment drug. Patients should be fasted for 8 hours in both solid and liquid preoperatively. After the surgery, allow a small amount of clear liquid to remain at the 4-hour fasting period after the operation, and allow the fluid to start within a tolerable range after 4 hours. The urinary catheter is removed on the first postoperative day and CPM rehabilitation is started from the afternoon. Post-operative ambulation should begin as early as possible on the second postoperative day.
All patients will undergo anesthesia for general anesthesia or spinal anesthesia with a nerve block (adductor canal block or femoral nerve block). The quality of recovery index was assessed on the day before surgery and on the POD 1 quality of recovery score (QoR) 40 questionnaire. And the length of hospital stay, first eating time, first assisted walking time, and start of rehabilitation after surgery of all patients will be recorded. The number of times that need antiemetics due to nausea / vomiting during the hospitalization period will be recorded. After discharge from the hospital, the patient will visit outpatient clinic at 4 ± 2 weeks postoperatively and will be checked a physical examination such as the ROM of the knee. At 3 ± 1 months and 6 ± 1 months after surgery, VAS, WOMAC, AKS, knee ROM, and PF score of all patients would be checked in outpatients clinic. In addition, morbidity, complications, mortality, and re-admission before and up to 6 months after surgery would be recorded.
- Conditions
- Arthroplasty, Replacement, Knee, Hip
- Being tested
- Enhanced recovery after surgery (ERAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgery (ERAS)Other
The patients in the ERAS group were given a pre-treatment drug [300 mg (gabapentin, Neurontin 300mg) and 10 mg oxycontin (oxycontin, Oxycontin CR 10mg) and 2 mg prednisolone (prednisolone 10 mg, Solondo 5mg)] on the evening before surgery. And pre-operative fasting should not exceed 6 hours, and clear liquid fasting should not exceed 2 hours. In addition, 400 ml of oral carbohydrate should be taken 2 to 4 hours before surgery to ensure adequate blood sugar and encourage regular diet (light meal) as soon as possible within a tolerable range after surgery. The initial pain after surgery is actively controlled by oral drugs such as celebrex and IR codon, and injections such as tramadol and demerol. On the first postoperative day, the urinary catheter is removed and CPM (continuous passive motion) rehabilitation is started.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced recovery after surgery (ERAS) patients | Experimental | Patients planned to undergoing total knee arthroplasty or total hip arthroplasty, following the ERAS perioperative care. Receives: Other: Enhanced recovery after surgery (ERAS) |
| Control patients | No intervention | Patients planned to undergoing total knee arthroplasty or total hip arthroplasty, following the traditional perioperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery score(QoR40)
Before surgery, QoR40 questionnaires will be used to compare the quality of recovery after anesthesia. QoR40 is a 40 items quality of recovery score that has been validated in a diverse group of patients. It is comprised of five dimensions which are physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item of the questionnaire is graded on a five-point Likert scale, and the global QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Measured: 1 day before surgery
Quality of recovery score(QoR40)
After surgery, QoR40 questionnaires will be used to compare the quality of recovery after anesthesia. QoR40 is a 40 items quality of recovery score that has been validated in a diverse group of patients. It is comprised of five dimensions which are physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item of the questionnaire is graded on a five-point Likert scale, and the global QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Measured: postoperative 1 day
Secondary outcomes (20)
Length of hospital stay
The investigators will record the entire length of hospital stay.
Measured: From pre-surgery to discharge, up to 4 weeks
First eating time
The investigators will record how soon the patients have started a normal meal, assisted walking and continuous passive movement rehabilitation after surgery.
Measured: From pre-surgery to discharge, up to 4 weeks
First assisted walking time
The investigators will record how soon the patients have started a normal meal, assisted walking and continuous passive movement rehabilitation after surgery.
Measured: From pre-surgery to discharge, up to 4 weeks
Start of rehabilitation(CPM)
The investigators will record how soon the patients have started a normal meal, assisted walking and continuous passive movement rehabilitation after surgery.
Measured: From pre-surgery to discharge, up to 4 weeks
Mortality
The investigators will investigate mortality up to 6 months after surgery.
Measured: up to 6 months after surgery
Morbidity
The investigators will investigate morbidity up to 6 months after surgery.
Measured: up to 6 months after surgery
Postoperative surgical complication
The investigators will investigate postoperative complication of surgery up to 6 months after surgery.
Measured: up to 6 months after surgery
Number of readmission
The investigators will investigate number of readmission up to 6 months after surgery.
Measured: up to 6 months after surgery
Clinical score of total joint arthroplasty (VAS)
The investigators will record the clinical score of total joint arthroplasty(VAS) at 3 months after surgery.
Measured: at postoperative 3±1 months
Clinical score of total joint arthroplasty (WOMAC)
The investigators will record the clinical score of total joint arthroplasty(WOMAC, The Western Ontario and McMaster Universities Arthritis) at 3 months after surgery.
Measured: at postoperative 3±1 months
Clinical score of total joint arthroplasty (AKS)
The investigators will record the clinical score of total joint arthroplasty(AKS, American knee society score) at 3 months after surgery.
Measured: at postoperative 3±1 months
Clinical score of total joint arthroplasty (knee ROM)
The investigators will record the clinical score of total joint arthroplasty(knee ROM) at 3 months after surgery.
Measured: at postoperative 3±1 months
Clinical score of total joint arthroplasty (Patellofemoral score)
The investigators will record the clinical score of total joint arthroplasty(Patellofemoral score) at 3 months after surgery.
Measured: at postoperative 3±1 months
Clinical score of total joint arthroplasty (Harris hip score)
The investigators will record the clinical score of total joint arthroplasty(Harris hip score) at 3 months after surgery.
Measured: at postoperative 3±1 months
Clinical score of total joint arthroplasty (VAS)
The investigators will record the clinical score of total joint arthroplasty(VAS) at 6 months after surgery.
Measured: at postoperative 6±1 months
Clinical score of total joint arthroplasty (WOMAC)
The investigators will record the clinical score of total joint arthroplasty(WOMAC, The Western Ontario and McMaster Universities Arthritis) at 6 months after surgery.
Measured: at postoperative 6±1 months
Clinical score of total joint arthroplasty (AKS)
The investigators will record the clinical score of total joint arthroplasty(AKS, American knee society score) at 6 months after surgery.
Measured: at postoperative 6±1 months
Clinical score of total joint arthroplasty (knee ROM)
The investigators will record the clinical score of total joint arthroplasty(knee ROM) at 6 months after surgery.
Measured: at postoperative 6±1 months
Clinical score of total joint arthroplasty (Patellofemoral score)
The investigators will record the clinical score of total joint arthroplasty(Patellofemoral score) at 6 months after surgery.
Measured: at postoperative 6±1 months
Clinical score of total joint arthroplasty (Harris hip score)
The investigators will record the clinical score of total joint arthroplasty(Harris hip score) at 6 months after surgery.
Measured: at postoperative 6±1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start10 May 2019
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, Knee, HipStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869203
- Sponsor's protocol ID
- 4-2019-0010
- Status last verified
- May 2019
- First submitted
- 6 Mar 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Impact of Enhanced Recovery After Surgery(ERAS) for Outcomes of Total Knee and Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03869203
- Acronym / sponsor ID
- 4-2019-0010
- Conditions
- Arthroplasty, Replacement, Knee, Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 11 Mar 2019 (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.
The purpose of this study is to analyze the effect of the ERAS(early recovery after surgery) protocol on total knee and hip arthroplasty compared to conventional standard protocol. Patients will be divided into two groups: ERAS protocol group and standard protocol group. On the day before the surgery, the patient group was randomly assigned by the researcher (research nurse) who did not participate in the surgical procedure. By comparing the clinical outcomes and quality of postoperative recovery of both groups, we could confirm the effect of ERAS protocol.
Detailed description
The patients who underwent radiologic examination at Severance Hospital of Severance Hospital and who will received total knee arthroplasty or total hip arthroplasty due to primary degenerative osteoarthritis or osteonecrosis of femoral head. Patients will be divided into two groups: ERAS (early recovery after surgery) protocol group and standard protocol group. On the day before the surgery, the patient group was randomly assigned by the researcher (research nurse) who did not participate in the surgical procedure.
The patients in the ERAS group were given a pre-treatment drug [300 mg (gabapentin) and 10 mg oxycontin (oxycontin) and 2 mg prednisolone (prednisolone 10 mg)] on the evening before surgery. And pre-operative fasting should not exceed 6 hours, and clear liquid fasting should not exceed 2 hours. In addition, 400 ml of oral carbohydrate should be taken 2 to 4 hours before surgery to ensure adequate blood sugar and encourage regular diet (light meal) as soon as possible within a tolerable range after surgery. The initial pain after surgery is actively controlled by oral drugs such as celebrex and IR codon, and injections such as tramadol and demerol. On the first postoperative day, the urinary catheter is removed and CPM (continuous passive motion) rehabilitation is started.
On the other hand, in standard group, there is no medication as a pre-treatment drug. Patients should be fasted for 8 hours in both solid and liquid preoperatively. After the surgery, allow a small amount of clear liquid to remain at the 4-hour fasting period after the operation, and allow the fluid to start within a tolerable range after 4 hours. The urinary catheter is removed on the first postoperative day and CPM rehabilitation is started from the afternoon. Post-operative ambulation should begin as early as possible on the second postoperative day.
All patients will undergo anesthesia for general anesthesia or spinal anesthesia with a nerve block (adductor canal block or femoral nerve block). The quality of recovery index was assessed on the day before surgery and on the POD 1 quality of recovery score (QoR) 40 questionnaire. And the length of hospital stay, first eating time, first assisted walking time, and start of rehabilitation after surgery of all patients will be recorded. The number of times that need antiemetics due to nausea / vomiting during the hospitalization period will be recorded. After discharge from the hospital, the patient will visit outpatient clinic at 4 ± 2 weeks postoperatively and will be checked a physical examination such as the ROM of the knee. At 3 ± 1 months and 6 ± 1 months after surgery, VAS, WOMAC, AKS, knee ROM, and PF score of all patients would be checked in outpatients clinic. In addition, morbidity, complications, mortality, and re-admission before and up to 6 months after surgery would be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced recovery after surgery (ERAS) patients | Experimental | Other: Enhanced recovery after surgery (ERAS)Patients planned to undergoing total knee arthroplasty or total hip arthroplasty, following the ERAS perioperative care. |
| Control patients | No intervention | –Patients planned to undergoing total knee arthroplasty or total hip arthroplasty, following the traditional perioperative care. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. elective total knee arthroplasty for degenerative osteoarthritis
- 2. elective total hip arthroplasty for osteoarthritis of osteonecrosis of femoral head
Key exclusion criteria (5 listed)
- 1. ASA class >3
- 2. severe medical comorbidities
- 3. inflammatory arthritis including rheumatoid arthritis
- 4. severe instability of knee or hip
- 5. revision surgery
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 |
|---|---|---|
| Enhanced recovery after surgery (ERAS)The patients in the ERAS group were given a pre-treatment drug [300 mg (gabapentin, Neurontin 300mg) and 10 mg oxycontin (oxycontin, Oxycontin CR 10mg) and 2 mg prednisolone (prednisolone 10 mg, Solondo 5mg)] on the evening before surgery. And pre-operative fasting should not exceed 6 hours, and clear liquid fasting should not exceed 2 hours. In addition, 400 ml of oral carbohydrate should be taken 2 to 4 hours before surgery to ensure adequate blood sugar and encourage regular diet (light meal) as soon as possible within a tolerable range after surgery. The initial pain after surgery is actively controlled by oral drugs such as celebrex and IR codon, and injections such as tramadol and demerol. On the first postoperative day, the urinary catheter is removed and CPM (continuous passive motion) rehabilitation is started. | Other | Enhanced recovery after surgery (ERAS) patients |
Primary outcome
Quality of recovery score(QoR40)
Time frame: 1 day before surgery
Before surgery, QoR40 questionnaires will be used to compare the quality of recovery after anesthesia. QoR40 is a 40 items quality of recovery score that has been validated in a diverse group of patients. It is comprised of five dimensions which are physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item of the questionnaire is graded on a five-point Likert scale, and the global QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Quality of recovery score(QoR40)
Time frame: postoperative 1 day
After surgery, QoR40 questionnaires will be used to compare the quality of recovery after anesthesia. QoR40 is a 40 items quality of recovery score that has been validated in a diverse group of patients. It is comprised of five dimensions which are physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item of the questionnaire is graded on a five-point Likert scale, and the global QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
20 secondary outcomes
Length of hospital stay
Time frame: From pre-surgery to discharge, up to 4 weeks
First eating time
Time frame: From pre-surgery to discharge, up to 4 weeks
First assisted walking time
Time frame: From pre-surgery to discharge, up to 4 weeks
Start of rehabilitation(CPM)
Time frame: From pre-surgery to discharge, up to 4 weeks
Mortality
Time frame: up to 6 months after surgery
Morbidity
Time frame: up to 6 months after surgery
Postoperative surgical complication
Time frame: up to 6 months after surgery
Number of readmission
Time frame: up to 6 months after surgery
Clinical score of total joint arthroplasty (VAS)
Time frame: at postoperative 3±1 months
Clinical score of total joint arthroplasty (WOMAC)
Time frame: at postoperative 3±1 months
Clinical score of total joint arthroplasty (AKS)
Time frame: at postoperative 3±1 months
Clinical score of total joint arthroplasty (knee ROM)
Time frame: at postoperative 3±1 months
Clinical score of total joint arthroplasty (Patellofemoral score)
Time frame: at postoperative 3±1 months
Clinical score of total joint arthroplasty (Harris hip score)
Time frame: at postoperative 3±1 months
Clinical score of total joint arthroplasty (VAS)
Time frame: at postoperative 6±1 months
Clinical score of total joint arthroplasty (WOMAC)
Time frame: at postoperative 6±1 months
Clinical score of total joint arthroplasty (AKS)
Time frame: at postoperative 6±1 months
Clinical score of total joint arthroplasty (knee ROM)
Time frame: at postoperative 6±1 months
Clinical score of total joint arthroplasty (Patellofemoral score)
Time frame: at postoperative 6±1 months
Clinical score of total joint arthroplasty (Harris hip score)
Time frame: at postoperative 6±1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: No
Related trials for Arthroplasty, Replacement, Knee, Hip
Recruiting
Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
Anxiety, Osteoarthritis
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Active, not recruiting
Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
Arthritis Knee, Arthritis Hip
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.
Department of Orthopedic Surgery, Yonsei University, College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery after surgery (ERAS) in people with Arthroplasty, Replacement, Knee, Hip, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 May 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery score(QoR40) (time frame: 1 day before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2019.