Hallux valgus
Conditions
Interventions
Test group:Intraoperatively, 1 g of tranexamic acid was sprayed on the osteotomy surface before closing the incision.
Control group:Intraoperatively, 1 g of saline was sprayed on the osteotomy surface before closing the incision.
Sponsors
Foot and Ankle Surgery, Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age =16 and =70 years old, male or female; (2) Meet the diagnostic criteria for moderate to severe hallux valgus, with preoperative Hallux Valgus angle (HVA) >20° and Intermetatarsal angle (IMA) >13°; (3) The patient's condition did not improve significantly after more than 3 months of conservative treatment; (4) The patients had not received ipsilateral forefoot surgery in the past; 5) Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, can independently complete a valid questionnaire, and are willing to follow up clinically according to the requirements of the study; (6) No contraindications to tranexamic acid and analgesic drugs such as flurbiprofen, aminophenol hydrocodone and tramadol.
Exclusion criteria
Exclusion criteria: 1) Previous ipsilateral forefoot surgery; 2) Previous history of venous thromboembolism; 3) Patients with contraindications to tranexamic acid as well as analgesic drugs such as flurbiprofen, aminophenol hydrocodone and tramadol; 4) Patients with severe hepatic or renal insufficiency, cardiovascular, cerebrovascular or other serious diseases; 5) patients with poorly controlled diabetes mellitus (glycated hemoglobin A1c > 8.0%) 6) Patients with osteoarthrosis and active infection of the first metatarsophalangeal joint; 7) Patients who need to combine other toe interphalangeal joints and metatarsophalangeal joints orthopedically at the same time during the operation; 8) Patients who are participating in other drug or medical device clinical trials and have not met their primary endpoints; 9) Patients who, in the opinion of the investigator, cannot participate in this clinical trial due to other circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forefoot circumference; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale, VAS;Anteroposterior diameter of the first metatarsal head;Length of the first metatarsal mid-division line and plantar plumb line measured on postoperative CT;Postoperative Foot Swelling Evaluation Form;Use of analgesic drugs for eruptive pain; | — |
Countries
China
Contacts
Public ContactNing Sun
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed