Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
NCT Number: NCT05204056
Sixty patients undergoing TKA were divided into three groups, then three different intro-operative articular cavity perfusion treatment was given according to the randomized, double-blind and controlled rule. One way ANOVA analysis on visual analogue scale (VAS) score, functional recovery, drainage, and edema of the affected limb were performed to assess the efficiency of the treatment in the following three days after the operation.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Yantai, Shandong, 264000, China
Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study, whilst subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded. After assessment, sixty qualified patients who voluntarily participating in this study have understood the research project were included in the present study and the corresponding consent forms were signed. Patients were randomly classified into three groups with different interventions, each group contains 20 patients. Group A: twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline; Group B twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic; the left twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group. All the study personnel including the patients, their family members, the nursing staff and the leading operator were blind to the treatment allocation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study. Kellgren-Lawrence Radiology standards for stage IV were listed as follows: obviously narrowed joint space; vast osteophytes are formed; severe osteosclerosis under the cartilage; bone hypertrophy and evident deformity
Exclusion criteria
Subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded.
Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy
Other names: H19983149
20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.
Other names: H43020565
Cocktail was formulated during the operation by mixing Ropivacaine 150mg, Morphine 10mg and Epinephrine 1mg, then normal saline was used to dilute the mixture to 60ml. Then the cocktail mixture was applied for the joint cavity perfusion.
Time frame: three days after operation
the pain after operation reduced significantly.
Time frame: 24 hours drainage.
The blood loss reduced significantly after operation.
Time frame: 3 days after operation
The HSS scores increased markedly after operation.
Yantai Yuhuangding Hospital
Other
Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty: Randomized Controlled Trial
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