Effect of Tergase Injection on Reducing Edema After Bilateral Total Knee Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorMan Soo Kim
About this trial
This clinical trial is conducted to compare and evaluate the efficacy and safety of Tergase injection (4,500 IU) in reducing postoperative edema between treated and untreated knees in patients undergoing bilateral total knee arthroplasty (TKA).
Prior to participation, all subjects receive a full explanation of the study and provide voluntary written informed consent. Only subjects who meet the inclusion and exclusion criteria through screening procedures are enrolled. Enrolled subjects are randomly assigned to the experimental and control groups in a 1:1 ratio per knee, utilizing a split-body clinical trial design that compares both knees of the same subject.
The analysis target is 60 knees obtained from a total of 30 subjects. According to the randomization results, the knee assigned to the experimental group receives a subcutaneous injection of 3 vials (4,500 IU) of Tergase, while the contralateral knee serves as the untreated control group.
By including both the experimental and control groups within the same subject, inter-individual variation is minimized. While the investigator performing the injection is aware of the assignment, the subject remains blinded.
To overcome the physical impossibility of blinding the injector due to the route of administration and drug characteristics, an 'Evaluator-Blinded' design is adopted to maintain objectivity equivalent to a double-blind study. To achieve this, the unblinded injector and the blinded evaluator who measures efficacy outcomes are strictly separated, and operational blinding is maintained by blocking information exchange between the two groups.
Subjects are evaluated for efficacy and safety during hospitalization or outpatient visits at Day 1, 2, 3, 5, Week 2, Week 6, and Month 3 after bilateral TKA. Participation ends upon completion of the planned visits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult males and females aged 60 years or older and 85 years or younger.
Patients scheduled for bilateral total knee arthroplasty due to degenerative knee osteoarthritis with a Kellgren-Lawrence grade of III or IV confirmed by imaging within the last 4 weeks.
Patients experiencing knee joint pain of 5 or higher on a 10-point Visual Analogue Scale (VAS) during daily activities, such as walking on flat ground.
Patients with the willingness and ability to follow the physician's instructions, including joint exercises.
Disqualifiers
Participants or their family members with ongoing or a history of autoimmune diseases.
Patients with secondary osteoarthritis of the knee.
Patients with inflammatory arthritis (such as rheumatoid arthritis, lupus arthropathy, psoriatic arthritis) or crystal-induced arthropathy.
Patients with a serum protein level of 5.5 g/dL or less.
Trial design
Design model
Parallel
Treatments tested in this trial
Berahyaluronidase alfa
DrugA total dose of 4,500 IU (3.0 mL; 3 vials) of berahyaluronidase alfa is administered subcutaneously around the suture line of the randomly assigned knee immediately after total knee arthroplasty. The dose is divided into 8 injection points, approximately 0.375 mL per point.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Tergase Injection KneeExperimental treatment 1 intervention
Group B: Untreated Control KneeNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Percent Change From Baseline in Composite Edema Index Based on Leg Circumference Measurements
The Composite Edema Index is calculated as the arithmetic mean of the percent change from preoperative baseline in leg circumference measured at four prespecified anatomical locations: calf at the thickest part, suprapatellar area just above the patella, infrapatellar area just below the patella, and thigh 10 cm above the patella. A higher percentage indicates greater postoperative edema.
Time frame
Baseline, Postoperative Day 2Secondary outcomes
1
Percent Change From Baseline in Mean Leg Circumference Swelling Rate
Mean leg circumference swelling rate is calculated as the arithmetic mean of the percent change from preoperative baseline in leg circumference measured at the same four prespecified anatomical locations. A higher percentage indicates greater postoperative swelling.
Time frame
Baseline, Postoperative Day 1, Day 3, Day 5, Week 2, Week 6, and Month 32
Change From Baseline in Mean Pain Intensity Score on a 0-to-10 Visual Analog Scale
Pain intensity is assessed using a 0-to-10 visual analog scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. The mean pain intensity score is calculated as the arithmetic mean of pain scores assessed at rest, during 60-degree knee flexion, and during walking. A higher score indicates greater pain intensity.
Time frame
Baseline, Postoperative Day 1, Day 2, Day 3, Day 5, Week 2, Week 6, and Month 33
Change From Baseline in Active Knee Flexion Range of Motion Measured With a Goniometer
Active knee flexion range of motion is measured in degrees using a goniometer. A higher value indicates greater knee flexion range of motion.
Time frame
Baseline, Postoperative Day 1, Day 2, Day 3, Day 5, Week 2, Week 6, and Month 34
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Total Score
The Western Ontario and McMaster Universities Osteoarthritis Index is a self-reported questionnaire consisting of 24 items across three domains: pain, stiffness, and physical function. The total score ranges from 0 to 96, with higher scores indicating greater pain, stiffness, and functional impairment.
Time frame
Baseline, Week 6, and Month 3Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Man Soo Kim
Lead sponsor
Seoul St. Mary's Hospital
Sponsor institution
Source ClinicalTrials.gov
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