Total Knee Arthroplasty (Replacement)NCT07828418
A Study on the Physiological Outcomes of the Enhanced Recovery After Surgery Model in Older Adults Undergoing Total Knee Arthroplasty
A study testing Enhanced Recovery After Surgery (ERAS) Care Pathway and Usual Perioperative Care in people with Total Knee Arthroplasty (Replacement), run by China Medical University Hospital.
Trial summary
With the advent of an aging society, the demand for total knee arthroplasty (TKA) continues to increase. Postoperative recovery is influenced not only by the surgical procedure itself but also by pain control, joint function, and physical resilience. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Total Knee Arthroplasty (Replacement)
- What is being tested?
- Enhanced Recovery After Surgery (ERAS) Care Pathway and Usual Perioperative Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older
- Scheduled to undergo primary unilateral elective total knee arthroplasty (TKA)
- Conscious and able to communicate in Mandarin Chinese or Taiwanese
- Willing to complete the study questionnaires and provide written informed consent
Who cannot join
- Cognitive impairment (e.g., moderate or severe dementia) or psychiatric illness that prevents adequate understanding, communication, or study participation
- Postoperative transfer to an intensive care unit, repeat surgery, or death
- Withdrawal of willingness to continue study participation during the study period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
With the advent of an aging society, the demand for total knee arthroplasty (TKA) continues to increase. Postoperative recovery is influenced not only by the surgical procedure itself but also by pain control, joint function, and physical resilience. Enhanced Recovery After Surgery (ERAS) promotes postoperative recovery through multidisciplinary integrated care; however, related research in Taiwan remains limited, particularly studies that simultaneously examine pain, joint function, and physical resilience.
This study aims to investigate the effects of the Enhanced Recovery After Surgery (ERAS) care model on changes in postoperative pain, knee function, and physical resilience among older adults undergoing total knee arthroplasty. A quasi-experimental study with convenience sampling will be conducted. Participants will be allocated to either the ERAS group or the routine care group according to the care model received. Outcome measurements will be obtained preoperatively, on postoperative day 1, postoperative day 3, and two weeks after discharge. Pain will be assessed using the Numeric Rating Scale (NRS), knee function using the Chinese version of the Knee Injury and Osteoarthritis Outcome Score (KOOS), and physical resilience using the Physical Resilience Instrument for Older Adults (PRIFOR). Clinical recovery indicators, including vital signs, length of hospital stay, and time to first ambulation, will also be collected.
The ERAS care model is expected to improve postoperative pain, promote recovery of knee function, enhance physical resilience, shorten the length of hospital stay, and facilitate earlier ambulation. The findings of this study are expected to provide evidence for optimizing perioperative care and supporting the implementation of ERAS for older adults undergoing total knee arthroplasty.
- Conditions
- Total Knee Arthroplasty (Replacement)
- Being tested
- Enhanced Recovery After Surgery (ERAS) Care Pathway, Usual Perioperative Care
- Keywords
- Enhanced Recovery After Surgery, Total Knee Arthroplasty, Older Adults, Pain, Knee Function, Physical Resilience
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS) Care PathwayOther
A standardized multidisciplinary perioperative care pathway including preoperative multidimensional assessment, preoperative education, nutritional assessment, multimodal pain management, intraoperative temperature maintenance, early oral intake, early ambulation, early rehabilitation, and discharge care.
Usual Perioperative CareOther
Usual perioperative care according to the hospital's current care pathway, including routine preoperative education, preoperative assessment, postoperative pain care, wound care, rehabilitation guidance, and discharge education.
| Study group | Role | What they receive |
|---|---|---|
| ERAS Group | Experimental | Participants in this group receive a standardized Enhanced Recovery After Surgery (ERAS) care pathway, including preoperative multidimensional assessment, preoperative education, nutritional assessment, multimodal pain management, intraoperative temperature maintenance, early oral intake, early ambulation, early rehabilitation, and discharge care. The ERAS pathway is delivered by a multidisciplinary healthcare team. Receives: Other: Enhanced Recovery After Surgery (ERAS) Care Pathway |
| Usual Care Group | Active comparator | Participants in this group receive the hospital's usual perioperative care, including routine preoperative education, preoperative assessment, postoperative pain care, wound care, rehabilitation guidance, and discharge education according to the hospital's current care pathway. Receives: Other: Usual Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Assessed by the Numerical Rating Scale (NRS)
Pain intensity will be assessed using the Numerical Rating Scale (NRS), with scores ranging from 0 to 10. Higher scores indicate greater pain intensity. Changes in pain scores will be compared between the ERAS group and the usual care group across the study time points.
Measured: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
Knee Function Assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee-related outcomes will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), which includes five subscales: Symptoms, Pain, Activities of Daily Living, Sport and Recreation Function, and Knee-related Quality of Life. Higher scores indicate better knee-related health status.
Measured: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
Physical Resilience Assessed by the Physical Resilience Instrument for Older Adults (PRIFOR)
Physical resilience will be assessed using the 16-item Physical Resilience Instrument for Older Adults (PRIFOR). Changes in physical resilience scores will be compared between the ERAS group and the usual care group across the study time points.
Measured: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty (Replacement)Studies of the same condition, open and under way.
- More trials run by China Medical University 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants choose either ERAS care or usual perioperative care after receiving information from the attending physician and are enrolled into the corresponding group. The study uses a non-randomized parallel-group design.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828418
- Sponsor's protocol ID
- CMUH115-REC3-148
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because data sharing is not included in the approved study protocol or informed consent. Study data will be maintained confidentially in accordance with institutional and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Physiological Outcomes of the Enhanced Recovery After Surgery Model in Older Adults Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07828418
- Acronym / sponsor ID
- CMUH115-REC3-148
- Conditions
- Total Knee Arthroplasty (Replacement)
- Keywords
- Enhanced Recovery After Surgery, Total Knee Arthroplasty, Older Adults, Pain, Knee Function, Physical Resilience
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Sep 2026 (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.
With the advent of an aging society, the demand for total knee arthroplasty (TKA) continues to increase. Postoperative recovery is influenced not only by the surgical procedure itself but also by pain control, joint function, and physical resilience. Enhanced Recovery After Surgery (ERAS) promotes postoperative recovery through multidisciplinary integrated care; however, related research in Taiwan remains limited, particularly studies that simultaneously examine pain, joint function, and physical resilience.
This study aims to investigate the effects of the Enhanced Recovery After Surgery (ERAS) care model on changes in postoperative pain, knee function, and physical resilience among older adults undergoing total knee arthroplasty. A quasi-experimental study with convenience sampling will be conducted. Participants will be allocated to either the ERAS group or the routine care group according to the care model received. Outcome measurements will be obtained preoperatively, on postoperative day 1, postoperative day 3, and two weeks after discharge. Pain will be assessed using the Numeric Rating Scale (NRS), knee function using the Chinese version of the Knee Injury and Osteoarthritis Outcome Score (KOOS), and physical resilience using the Physical Resilience Instrument for Older Adults (PRIFOR). Clinical recovery indicators, including vital signs, length of hospital stay, and time to first ambulation, will also be collected.
The ERAS care model is expected to improve postoperative pain, promote recovery of knee function, enhance physical resilience, shorten the length of hospital stay, and facilitate earlier ambulation. The findings of this study are expected to provide evidence for optimizing perioperative care and supporting the implementation of ERAS for older adults undergoing total knee arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants choose either ERAS care or usual perioperative care after receiving information from the attending physician and are enrolled into the corresponding group. The study uses a non-randomized parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| ERAS Group | Experimental | Other: Enhanced Recovery After Surgery (ERAS) Care PathwayParticipants in this group receive a standardized Enhanced Recovery After Surgery (ERAS) care pathway, including preoperative multidimensional assessment, preoperative education, nutritional assessment, multimodal pain management, intraoperative temperature maintenance, early oral intake, early ambulation, early rehabilitation, and discharge care. The ERAS pathway is delivered by a multidisciplinary healthcare team. |
| Usual Care Group | Active comparator | Other: Usual Perioperative CareParticipants in this group receive the hospital's usual perioperative care, including routine preoperative education, preoperative assessment, postoperative pain care, wound care, rehabilitation guidance, and discharge education according to the hospital's current care pathway. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65 years or older
- Scheduled to undergo primary unilateral elective total knee arthroplasty (TKA)
- Conscious and able to communicate in Mandarin Chinese or Taiwanese
- Willing to complete the study questionnaires and provide written informed consent
Key exclusion criteria (3 listed)
- Cognitive impairment (e.g., moderate or severe dementia) or psychiatric illness that prevents adequate understanding, communication, or study participation
- Postoperative transfer to an intensive care unit, repeat surgery, or death
- Withdrawal of willingness to continue study participation during the study period
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) Care PathwayA standardized multidisciplinary perioperative care pathway including preoperative multidimensional assessment, preoperative education, nutritional assessment, multimodal pain management, intraoperative temperature maintenance, early oral intake, early ambulation, early rehabilitation, and discharge care. | Other | ERAS Group |
| Usual Perioperative CareUsual perioperative care according to the hospital's current care pathway, including routine preoperative education, preoperative assessment, postoperative pain care, wound care, rehabilitation guidance, and discharge education. | Other | Usual Care Group |
Primary outcome
Pain Intensity Assessed by the Numerical Rating Scale (NRS)
Time frame: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
Pain intensity will be assessed using the Numerical Rating Scale (NRS), with scores ranging from 0 to 10. Higher scores indicate greater pain intensity. Changes in pain scores will be compared between the ERAS group and the usual care group across the study time points.
Knee Function Assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
Knee-related outcomes will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), which includes five subscales: Symptoms, Pain, Activities of Daily Living, Sport and Recreation Function, and Knee-related Quality of Life. Higher scores indicate better knee-related health status.
Physical Resilience Assessed by the Physical Resilience Instrument for Older Adults (PRIFOR)
Time frame: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge
Physical resilience will be assessed using the 16-item Physical Resilience Instrument for Older Adults (PRIFOR). Changes in physical resilience scores will be compared between the ERAS group and the usual care group across the study time points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because data sharing is not included in the approved study protocol or informed consent. Study data will be maintained confidentially in accordance with institutional and ethical requirements.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery (ERAS) Care Pathway and Usual Perioperative Care in people with Total Knee Arthroplasty (Replacement), run by China Medical University Hospital.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Tung-Chieh Lin Tung-Chieh, Principal Investigator (+886-972-856-864, n16548@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessed by the Numerical Rating Scale (NRS) (time frame: Preoperative day, postoperative day 1, postoperative day 3, and 2 weeks after discharge). The study lists 3 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 21 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.