Heterotopic ossification after elbow joint fracture
Conditions
Interventions
Group A (TXA group):5~10 minutes before skin incision, TXA (BaiLing, Chongqing, NMPA approval number H20031101, 100 mL:1 g) was intravenously infused at a dose of 20mg/kg, and 1 g of TXA was intraveno
Group B (indomethacin group):Postoperatively, the patients were given oral sustained-release indomethacin capsules once daily, with a dose of 75mg per capsule for a total duration of 6 weeks.
Group C (TXA+indomethacin group): intravenous infusion of tranexamic acid (TXA) (Beining, Chongqing, National Medicine Approval No. H20031101, 100 mL:1 g) at a dose of 20mg/kg 5-10 minutes before skin
Sponsors
Sichuan Provincial Orthopedic Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Patients with closed fractures around the elbow joint who undergo open reduction and internal fixation with steel plates and screws. Closed fractures around the elbow joint include distal humeral fractures, proximal ulnar fractures, radial head fractures, and terrible triad of the elbow. 2) Patients aged between 18 (inclusive) and 80 (inclusive) years old. 3) Patients who understand the purpose of the clinical trial, voluntarily participate and have good compliance.
Exclusion criteria
Exclusion criteria: 1) Patients with abnormal platelet count and/or function before surgery; 2) Patients with abnormal function of the coagulation and/or fibrinolytic system before surgery; 3) Patients with a history of recent (within 3-6 months) cerebral hemorrhage or cerebral infarction; 4) Patients at high risk of thrombosis, such as those with atrial fibrillation or those who have undergone coronary stent implantation; 5) Patients who have taken anticoagulant or antiplatelet drugs such as aspirin, and have stopped taking them for less than 1 week; 6) Patients with preoperative liver or kidney dysfunction; 7) Patients who have allergies to TXA or are contraindicated for its use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elbow joint heterotopic ossification incidence and grading;Elbow circumference; Elbow joint range of motion;Elbow ASH score and Mayo score;Total Blood Loss,TBL;Intraoperative Blood Loss, IBL;Hidden Blood Loss, HBL;D-dimer;fibrinogen degradation products, FDP;Interleukin 6;c reactive protein, CRP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum decrease in Hb;Transfusion rate and volume of transfusion;VAS score;Amount of opioid use; Length of hospital stay after surgery; | — |
Countries
China
Contacts
Public ContactChen Guo
Sichuan Provincial Orthopedic Hospital
Outcome results
None listed