The effect of a bracelet on gastrointestinal recovery after unicompartmental knee arthroplasty
| ISRCTN | ISRCTN70004676 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70004676 |
| Secondary identifying numbers | 2024ZXKT0009-01, 82104896 |
- Submission date
- 06/11/2024
- Registration date
- 20/01/2025
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
With the increasing ageing population, the incidence of knee joint degeneration is increasing year by year. Unicompartmental knee arthroplasty (UKA) is surgery used to treat end-stage knee joint diseases, which can significantly relieve pain and correct deformity. Postoperative nausea and vomiting (PONV) and constipation are common complications of UKA. Therefore, reducing the incidence of nausea and vomiting is the focus of attention and research at present. The application of a non-invasive anti-vertigo bracelet can effectively stimulate relevant acupoints, reduce the incidence of PONV and promote the rehabilitation of patients, but it has not been applied to the research in the field of joint replacement. Therefore, this study intends to verify the effect of a non-invasive anti-vertigo bracelet in preventing knee replacement PONV.
Who can participate?
Patients aged 18 - 75 years who need UKA due to end-stage osteoarthritis
What does the study involve?
All patients received the same perioperative management and drug treatment. The incidence of PONV at different timepoints (3, 6, 12 and 24 hours after the operation) was measured, and the curative effect of the bracelet on PONV after the operation was observed and analyzed.
What are the possible benefits and risks of participating?
Possible risks of the surgery include deep venous thrombosis, knee joint stiffness, and acute knee infection. The benefits of participation include a better understanding of the effect of the bracelet on postoperative PONV after joint replacement.
Where is the study run from?
Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province (China)
When is the study starting and how long is it expected to run for?
January 2025 to December 2025
Who is funding the study?
1. National Natural Science Foundation of China
2. Project of Science and Technology of Henan Province (China)
Who is the main contact?
Guorui Cao, 13688172272@163.com
Contact information
Public, Scientific, Principal Investigator
82 Qiming South Road
Luoyang
471000
China
| Phone | +86 (0)13258289917 |
|---|---|
| 13688172272@163.com |
Study information
| Study design | Parallel randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Prevention, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of EmeTerm® bracelet on gastrointestinal reaction following unicompartmental knee arthroplasty |
| Study objectives | This study aims to evaluate the effect of the EmeTerm® bracelet in preventing nausea, vomiting and constipation in patients undergoing unicompartmental knee arthroplasty |
| Ethics approval(s) |
Approved 01/01/2025, Luoyang Orthopedic Hospital of Henan Province Ethics Committee (82 Qiming South Road, Luoyang, 471000, China; +86 (0)13258289917; hnlc.love@163.com), ref: 2024ZXKT0009-01 |
| Health condition(s) or problem(s) studied | Postoperative nausea, vomiting and constipation in patients undergoing knee replacement |
| Intervention | Using an acupoint stimulation bracelet (EmeTerm®) All patients received the same perioperative management and drug treatment. The incidence of PONV at different time points (3, 6, 12 and 24 hours after the operation) was measured, and the curative effect of SDZ-V on PONV after the operation was observed and analyzed. |
| Intervention type | Other |
| Primary outcome measure | The incidence of PONV measured using questionnaire at 3, 6, 12 and 24 hours after the operation |
| Secondary outcome measures | 1. The severity of nausea and vomiting measured using questionnaire in the 24 hours after the operation 2. First exhaust time and defecation time after the operation, measured using questionnaire 3. Levels of hemoglobin, albumin and electrolyte in blood measured using hospital monitoring system after the operation 4. The incidence of constipation measured using questionnaire at 3 days after the operation 5. Stratified analysis on the basis of anesthesia method and the risk of nausea and vomiting |
| Overall study start date | 01/01/2025 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 240 |
| Key inclusion criteria | 1. Patients aged 18 to 75 years who need knee replacement due to end-stage osteoarthritis 2. Patients who voluntarily participate in clinical trials and sign informed consent forms with good compliance |
| Key exclusion criteria | 1. Patients undergoing revision and bilateral joint replacement 2. Patients who have received acupuncture treatment within 2 weeks 3. Patients with rheumatoid disease, systemic lupus erythematosus and ankylosing spondylitis 4. Patients with severe deformity of knee joint (knee flexion ≥30 degrees, varus ≥30 degrees or valgus ≥15 degrees) 5. severe hepatic and renal insufficiency 6. Patients with central nervous system or mental illness 7. Those who are experiencing nausea, vomiting, diarrhea or constipation, and those who are taking drugs or non-drugs to treat nausea, vomiting, diarrhea or constipation, and those who are taking drugs that affect gastrointestinal motility 8. Skin allergy, breakage, infection or itching at the test site, etc |
| Date of first enrolment | 10/01/2025 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Luoyang
610041
China
Sponsor information
Hospital/treatment centre
No 82, Qiming South Road
Luoyang
471000
China
| Phone | +86 (0)15713792777 |
|---|---|
| hnsgkyyhr@126.com | |
| Website | https://www.lyzhenggu.cn/ |
"ROR" |
https://ror.org/05br7cm44 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Guorui Cao, 13688172272@163.com |
Editorial Notes
06/11/2024: Study's existence confirmed by the Luoyang Orthopedic Hospital of Henan Province Ethics Committee.
