The effect of a bracelet on gastrointestinal recovery after unicompartmental knee arthroplasty
| ISRCTN | ISRCTN70004676 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70004676 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2024ZXKT0009-01, 82104896 |
| Sponsor | Luoyang Orthopedic-Traumatological Hospital of Henan Province |
| Funder | National Natural Science Foundation of China |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Parallel randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
The incidence of PONV measured using questionnaire at 3, 6, 12 and 24 hours after the operation |
| Key secondary outcome measure(s) |
1. The severity of nausea and vomiting measured using questionnaire in the 24 hours after the operation |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Guorui Cao, 13688172272@163.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/11/2024: Study's existence confirmed by the Luoyang Orthopedic Hospital of Henan Province Ethics Committee.
