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Effect of Tergase Injection on Reducing Edema After Bilateral Total Knee Arthroplasty (ALT-TKA)

2026년 7월 12일 업데이트: Man Soo Kim

A Randomized, Split Body, Evaluator-blinded, Trial on the Effect of Tergase Injection (Berahyaluronidase Alfa) on Reducing Edema After Both Total Knee Arthroplasty

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Adult males and females aged 60 years or older and 85 years or younger.
  2. 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.
  3. 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.
  4. Patients with the willingness and ability to follow the physician's instructions, including joint exercises.
  5. Patients classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.
  6. Patients who have received a full explanation of the clinical trial and have voluntarily provided written informed consent to participate.

Exclusion Criteria:

  1. Participants or their family members with ongoing or a history of autoimmune diseases.
  2. Patients with secondary osteoarthritis of the knee.
  3. Patients with inflammatory arthritis (such as rheumatoid arthritis, lupus arthropathy, psoriatic arthritis) or crystal-induced arthropathy.
  4. Patients with a serum protein level of 5.5 g/dL or less.

  5. Patients with clinical laboratory results that are contraindications for total knee arthroplasty:

    1. WBC <3,000/μL or >12,000/μL
    2. CRP >10 mg/L
    3. Hb <10 g/dL
    4. Platelet count <100,000/μL
    5. INR >1.5
    6. eGFR <30 mL/min/1.73 m²
    7. AST or ALT >3 times the upper limit of normal
    8. Fasting blood glucose >200 mg/dL
  6. Patients with a history of drug abuse or dependence.
  7. Presence of local infection or sepsis in the affected lower limb, or a history of neurological abnormalities within the past 6 months.
  8. History of major joint surgery within 90 days.
  9. Patients who received systemic steroid treatment within 3 months prior to surgery.
  10. Patients who sustained a serious injury or received an injection in the target knee that may interfere with evaluation within 3 months prior to the screening visit.
  11. Patients with infections requiring hospitalization and administration of antibiotics or antimicrobics.

  12. Patients with any clinically significant medical condition that may interfere with study completion or outcome assessment, including but not limited to:

    1. Congenital heart disease, clinically significant cardiovascular disease, renal dysfunction, or uncontrolled diabetes.
    2. Neuromuscular disorders affecting the lower limbs.
    3. Severe bleeding or coagulation disorders.
    4. Severe knee instability that cannot be corrected with cruciate-retaining total knee arthroplasty.
    5. Severe knee deformity, defined as flexion contracture ≥30 degrees or varus/valgus deformity ≥30 degrees.
    6. Opioid dependence, defined as consumption of ≥100 mg morphine-equivalent opioids per week for more than 3 months before surgery.
    7. Inability to assess pain using the Visual Analogue Scale, including cognitive or language impairment.
    8. Venous congestion of the lower extremity.
    9. Morbid obesity, defined as body mass index >40 kg/m².
  13. History of shock or hypersensitivity to Tergase inj. or its components.
  14. Patients deemed unsuitable for this study by the investigator, such as those with psychiatric disorders.
  15. Patients currently participating in another clinical trial.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
의약품: Berahyaluronidase alfa
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.
다른 이름들:
  • 재조합 인간 히알루로니다아제
  • Tergase Inj.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percent Change From Baseline in Composite Edema Index Based on Leg Circumference Measurements
기간: Baseline, Postoperative Day 2
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.
Baseline, Postoperative Day 2

2차 결과 측정

결과 측정
측정값 설명
기간
Percent Change From Baseline in Mean Leg Circumference Swelling Rate
기간: Baseline, Postoperative Day 1, Day 3, Day 5, Week 2, Week 6, and Month 3
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.
Baseline, Postoperative Day 1, Day 3, Day 5, Week 2, Week 6, and Month 3
Change From Baseline in Mean Pain Intensity Score on a 0-to-10 Visual Analog Scale
기간: Baseline, Postoperative Day 1, Day 2, Day 3, Day 5, Week 2, Week 6, and Month 3
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.
Baseline, Postoperative Day 1, Day 2, Day 3, Day 5, Week 2, Week 6, and Month 3
Change From Baseline in Active Knee Flexion Range of Motion Measured With a Goniometer
기간: Baseline, Postoperative Day 1, Day 2, Day 3, Day 5, Week 2, Week 6, and Month 3
Active knee flexion range of motion is measured in degrees using a goniometer. A higher value indicates greater knee flexion range of motion.
Baseline, Postoperative Day 1, Day 2, Day 3, Day 5, Week 2, Week 6, and Month 3
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Total Score
기간: Baseline, Week 6, and Month 3
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.
Baseline, Week 6, and Month 3
CT-Measured Mean Lower Extremity Soft Tissue Thickness at Postoperative Day 2
기간: Postoperative Day 2
Lower extremity CT scans are used to measure soft tissue thickness at prespecified anatomical locations corresponding to the circumference measurement sites. The value is reported in millimeters as the mean thickness across the prespecified locations. A higher value indicates greater soft tissue thickness.
Postoperative Day 2
Change From Baseline in Serum C-Reactive Protein Concentration
기간: Baseline, Postoperative Day 1, Week 2, and Month 3
Serum C-reactive protein concentration is measured using fasting blood samples to evaluate the systemic inflammatory response after surgery. Values are reported in mg/L. A higher value indicates a greater inflammatory response.
Baseline, Postoperative Day 1, Week 2, and Month 3
Change From Baseline in Serum Amyloid A Concentration
기간: Baseline, Postoperative Day 1, Week 2, and Month 3
Serum amyloid A concentration is measured using fasting blood samples to evaluate the systemic inflammatory response after surgery. Values are reported in mg/L. A higher value indicates a greater inflammatory response.
Baseline, Postoperative Day 1, Week 2, and Month 3
Number of Participants With at Least One Predefined Postoperative Complication
기간: From immediately after surgery through postoperative Month 3
Predefined postoperative complications include nausea, vomiting, falls, subcutaneous hemorrhage, vascular injury, wound complications, and venous thromboembolism. Participants are counted once if they experience one or more predefined postoperative complications during the assessment period.
From immediately after surgery through postoperative Month 3
Number of Participants With at Least One Adverse Event
기간: From investigational product administration through postoperative Month 3
Adverse events and serious adverse events occurring after investigational product administration are collected during the study period. Participants are counted once if they experience one or more adverse events, excluding predefined postoperative complications captured separately.
From investigational product administration through postoperative Month 3
Number of Participants With Clinically Significant Abnormal Vital Sign Findings
기간: From Screening Visit through postoperative Month 3
Clinically significant abnormal vital sign findings are defined as any investigator-assessed clinically significant abnormality in blood pressure, pulse rate, or body temperature during the study period. Participants are counted once if they experience one or more clinically significant abnormal vital sign findings.
From Screening Visit through postoperative Month 3
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
기간: From Screening Visit through postoperative Month 3
Clinically significant abnormal physical examination findings are defined as any new or worsened abnormal finding identified by the investigator during the study period. Participants are counted once if they experience one or more clinically significant abnormal physical examination findings.
From Screening Visit through postoperative Month 3
Number of Participants With Clinically Significant Abnormal Clinical Laboratory Test Results
기간: From Screening Visit through postoperative Month 3
Clinically significant abnormal clinical laboratory test results are defined as any investigator-assessed clinically significant abnormality in hematology, blood chemistry, coagulation, or urinalysis results during the study period. Participants are counted once if they experience one or more clinically significant abnormal clinical laboratory test results.
From Screening Visit through postoperative Month 3

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Man Soo Kim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2028년 1월 31일

연구 완료 (추정된)

2028년 3월 31일

연구 등록 날짜

최초 제출

2026년 5월 14일

QC 기준을 충족하는 최초 제출

2026년 7월 12일

처음 게시됨 (실제)

2026년 7월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 12일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • XC26MIDI0010
  • KCT0011945 (레지스트리 식별자: Clinical Research Information Service (CRIS))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Berahyaluronidase alfa에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Lebanon

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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