Clinical efficacy and safety of temperature sensitive antiadhesive agent

Not Applicable

Completed

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0002185
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Patients who agree with participate in studies
2) Age : 50 - 79 years
3) Patients who was no significant unusual findings in preoperative evaluation
4) Patients who will be taken total knee arthroplasy by primary osteoarthritis of the knee

Exclusion Criteria

1) Patients who participated other studies that medicated drug or treated by medical device 1 month before register this study
2) Previous operative history of ipsilateral knee
3) Patients who will be treated by anti-platelet agent or general steroid within 1 weeks after total knee arthroplasty
4) Patients who diagnosed immunosuppressive disease or autoimmune disease
5) Patients who have allergy on anti-adhesive agent we used
6) Patients who have general infection or infection around the knee joint
7) Patients who diagnosed severe diseases that may affect the operation(for example, heart failure, kidney failure, liver failure, uncontrolled blood pressure, uncontrolled DM, uncontrolled anticoagulation disease)
8) Patients who will take banned medicines in combination during clinical trial
9) Patients who addicted alcohol or medicine, and patients who had psychiatric illness
10) Patients who had history of Parkinson disease, sequelae of poliomyelitis, stroke
11) Patients who had high risk of surgery due to accompanying cardiopulmonary diseases and general disease
12) Patients who require bone graft, block, or long stem due to severe articular destruction and deformity
13) Patients who had difficulty participating clinical trial by judge of the director of clinical trial
14) Pregnant woman or lactating woman

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
knee range of motion

Secondary Outcome Measures

Name	Time	Method
skin fold of operation site;Visual analogue Score;Check the adhesion of operation site by ultrasonography;the amount of blood loss, blood transfusion;the amount of analgesics and Patient Controlled Analgesics