Effect of Tergase Injection on Reducing Edema After Bilateral Total Knee Arthroplasty

Sponsor
Man Soo Kim
Study ID
NCT07705165
Status
Not Yet Recruiting

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Conditions

  • Bilateral Total Knee Arthroplasty
  • Osteoarthritis, Knee
  • Postoperative Edema

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Berahyaluronidase alfa — DRUG
    A 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.

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tergase Injection Knee
    One knee of the subject, randomly assigned to receive a subcutaneous injection of 4,500 IU (3 vials) of Tergase (Berahyaluronidase alfa) at 8 points immediately after total knee arthroplasty (TKA).
  • No Intervention: Untreated Control Knee
    The contralateral knee of the same subject which does not receive any injection, serving as a self-control for efficacy and safety comparisons.

Primary Outcome Measure

Percent Change From Baseline in Composite Edema Index Based on Leg Circumference Measurements [ Time Frame: Baseline, Postoperative Day 2 ]

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