Osteoarthritis, KneeALT-TKANCT07705165
Effect of Tergase Injection on Reducing Edema After Bilateral Total Knee Arthroplasty
A study testing Berahyaluronidase alfa in people with Osteoarthritis, Knee and Postoperative Edema, run by Man Soo Kim.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee, Postoperative Edema, Bilateral Total Knee Arthroplasty
- What is being tested?
- Berahyaluronidase alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.
- Patients who have received a full explanation of the clinical trial and have voluntarily provided written informed consent to participate.
Who cannot join
- 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.
- Patients with clinical laboratory results that are contraindications for total knee arthroplasty:
- WBC <3,000/μL or >12,000/μL
Show all 32Show fewer
- CRP >10 mg/L
- Hb <10 g/dL
- Platelet count <100,000/μL
- INR >1.5
- eGFR <30 mL/min/1.73 m²
- AST or ALT >3 times the upper limit of normal
- Fasting blood glucose >200 mg/dL
- Patients with a history of drug abuse or dependence.
- Presence of local infection or sepsis in the affected lower limb, or a history of neurological abnormalities within the past 6 months.
- History of major joint surgery within 90 days.
- Patients who received systemic steroid treatment within 3 months prior to surgery.
- 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.
- Patients with infections requiring hospitalization and administration of antibiotics or antimicrobics.
- Patients with any clinically significant medical condition that may interfere with study completion or outcome assessment, including but not limited to:
- Congenital heart disease, clinically significant cardiovascular disease, renal dysfunction, or uncontrolled diabetes.
- Neuromuscular disorders affecting the lower limbs.
- Severe bleeding or coagulation disorders.
- Severe knee instability that cannot be corrected with cruciate-retaining total knee arthroplasty.
- Severe knee deformity, defined as flexion contracture ≥30 degrees or varus/valgus deformity ≥30 degrees.
- Opioid dependence, defined as consumption of ≥100 mg morphine-equivalent opioids per week for more than 3 months before surgery.
- Inability to assess pain using the Visual Analogue Scale, including cognitive or language impairment.
- Venous congestion of the lower extremity.
- Morbid obesity, defined as body mass index >40 kg/m².
- History of shock or hypersensitivity to Tergase inj. or its components.
- Patients deemed unsuitable for this study by the investigator, such as those with psychiatric disorders.
- Patients currently participating in another clinical trial.
About this study
Official title: 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.
Read more
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.
- Being tested
- Berahyaluronidase alfa
- Keywords
- Tergase, Berahyaluronidase alfa, Recombinant human hyaluronidase, Total Knee Arthroplasty, Postoperative Edema, Split-body trial
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berahyaluronidase alfaDrug
Also called Tergase Inj., Recombinant human hyaluronidase
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 group | Role | What they receive |
|---|---|---|
| Tergase Injection Knee | Experimental | 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). Receives: Drug: Berahyaluronidase alfa |
| Untreated Control Knee | No intervention | The contralateral knee of the same subject which does not receive any injection, serving as a self-control for efficacy and safety comparisons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Postoperative Day 2
Secondary outcomes (12)
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.
Measured: 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
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.
Measured: 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
Active knee flexion range of motion is measured in degrees using a goniometer. A higher value indicates greater knee flexion range of motion.
Measured: 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
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.
Measured: Baseline, Week 6, and Month 3
CT-Measured Mean Lower Extremity Soft Tissue Thickness at 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.
Measured: Postoperative Day 2
Change From Baseline in Serum C-Reactive Protein Concentration
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.
Measured: Baseline, Postoperative Day 1, Week 2, and Month 3
Change From Baseline in Serum Amyloid A Concentration
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.
Measured: Baseline, Postoperative Day 1, Week 2, and Month 3
Number of Participants With at Least One Predefined Postoperative Complication
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.
Measured: From immediately after surgery through postoperative Month 3
Number of Participants With at Least One Adverse Event
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.
Measured: From investigational product administration through postoperative Month 3
Number of Participants With Clinically Significant Abnormal Vital Sign Findings
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.
Measured: From Screening Visit through postoperative Month 3
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
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.
Measured: From Screening Visit through postoperative Month 3
Number of Participants With Clinically Significant Abnormal Clinical Laboratory Test Results
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.
Measured: From Screening Visit through postoperative Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, split-body, evaluator-blinded study. Each participant receives the intervention on one randomly assigned knee, while the other knee serves as an untreated control * Intervention Type: Drug * Intervention Name: Tergase Inj. (Berahyaluronidase alfa) * Description: 4,500 IU (3.0 mL) divided into 8 points (approx. 0.375 mL per point) injected subcutaneously around the suture line.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Man Soo Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Man Soo Kim, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705165
- Sponsor's protocol ID
- XC26MIDI0010
- Other IDs
- KCT0011945
- Acronym
- ALT-TKA
- Status last verified
- Jul 2026
- First submitted
- 14 May 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwon H, Park HS, Shim JY, Lee KW, Choi SJ, Choi GY. Randomized, Double-Blind, Placebo-Controlled Trial on the Efficacy of Hyaluronidase in Preventing Perineal Trauma in Nulliparous Women. Yonsei Med J. 2020 Jan;61(1):79-84. doi: 10.3349/ymj.2020.61.1.79.
PubMed 31887803Alam M, Hughart R, Geisler A, Paghdal K, Maisel A, Weil A, West DP, Veledar E, Poon E. Effectiveness of Low Doses of Hyaluronidase to Remove Hyaluronic Acid Filler Nodules: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jul 1;154(7):765-772. doi: 10.1001/jamadermatol.2018.0515.
PubMed 29710212Kwoen MJ, Choi YH, Kim KS, Chang NH, Kim YK, Lee HJ. Efficacy of local hyaluronidase administration in guided bone regeneration surgery: a randomized controlled trial. J Korean Assoc Oral Maxillofac Surg. 2021 Apr 30;47(2):91-98. doi: 10.5125/jkaoms.2021.47.2.91.
PubMed 33911041Koc O, Er N, Karaca C, Bilginaylar K. Comparison of the effects of submucosal hyaluronidase and dexamethasone on postoperative edema, pain, trismus, and infection following impacted third molar surgery. BMC Oral Health. 2024 Aug 30;24(1):1018. doi: 10.1186/s12903-024-04729-1.
PubMed 39215323Wang Q, Jin Q, Cai L, Zhao C, Feng P, Jia J, Xu W, Qian Q, Ding Z, Xu J, Gu C, Zhang S, Shi H, Ma H, Deng Y, Zhang T, Song Y, Wang Q, Zhang Y, Zhou X, Pei L, Yang Y, Liang J, Jiang T, Li H, Liu H, Wu L, Kang P. Efficacy of Diosmin in Reducing Lower-Extremity Swelling and Pain After Total Knee Arthroplasty: A Randomized, Controlled Multicenter Trial. J Bone Joint Surg Am. 2024 Mar 20;106(6):492-500. doi: 10.2106/JBJS.23.00854. Epub 2023 Dec 18.
PubMed 38109425
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Split Body, Evaluator-blinded, Trial on the Effect of Tergase Injection (Berahyaluronidase Alfa) on Reducing Edema After Both Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07705165
- Acronym / sponsor ID
- ALT-TKA / XC26MIDI0010
- Keywords
- Tergase, Berahyaluronidase alfa, Recombinant human hyaluronidase, Total Knee Arthroplasty, Postoperative Edema, Split-body trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Man Soo KimUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, split-body, evaluator-blinded study. Each participant receives the intervention on one randomly assigned knee, while the other knee serves as an untreated control * Intervention Type: Drug * Intervention Name: Tergase Inj. (Berahyaluronidase alfa) * Description: 4,500 IU (3.0 mL) divided into 8 points (approx. 0.375 mL per point) injected subcutaneously around the suture line.
| Arm | Type | Receives |
|---|---|---|
| Tergase Injection Knee | Experimental | Drug: Berahyaluronidase alfaOne 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). |
| Untreated Control Knee | No intervention | –The contralateral knee of the same subject which does not receive any injection, serving as a self-control for efficacy and safety comparisons. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Patients classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.
Key exclusion criteria (32 listed)
- 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.
- Patients with clinical laboratory results that are contraindications for total knee arthroplasty:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berahyaluronidase alfaAlso: Tergase Inj., Recombinant human hyaluronidaseA 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. | Drug | Tergase Injection Knee |
Primary outcome
Percent Change From Baseline in Composite Edema Index Based on Leg Circumference Measurements
Time frame: 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.
12 secondary outcomes
Percent Change From Baseline in Mean Leg Circumference Swelling Rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 6, and Month 3
CT-Measured Mean Lower Extremity Soft Tissue Thickness at Postoperative Day 2
Time frame: Postoperative Day 2
Change From Baseline in Serum C-Reactive Protein Concentration
Time frame: Baseline, Postoperative Day 1, Week 2, and Month 3
Change From Baseline in Serum Amyloid A Concentration
Time frame: Baseline, Postoperative Day 1, Week 2, and Month 3
Number of Participants With at Least One Predefined Postoperative Complication
Time frame: From immediately after surgery through postoperative Month 3
Number of Participants With at Least One Adverse Event
Time frame: From investigational product administration through postoperative Month 3
Number of Participants With Clinically Significant Abnormal Vital Sign Findings
Time frame: From Screening Visit through postoperative Month 3
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time frame: From Screening Visit through postoperative Month 3
Number of Participants With Clinically Significant Abnormal Clinical Laboratory Test Results
Time frame: From Screening Visit through postoperative Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 31887803Kwon H, Park HS, Shim JY, Lee KW, Choi SJ, Choi GY. Randomized, Double-Blind, Placebo-Controlled Trial on the Efficacy of Hyaluronidase in Preventing Perineal Trauma in Nulliparous Women. Yonsei Med J. 2020 Jan;61(1):79-84. doi: 10.3349/ymj.2020.61.1.79.
- Background: PubMed 29710212Alam M, Hughart R, Geisler A, Paghdal K, Maisel A, Weil A, West DP, Veledar E, Poon E. Effectiveness of Low Doses of Hyaluronidase to Remove Hyaluronic Acid Filler Nodules: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jul 1;154(7):765-772. doi: 10.1001/jamadermatol.2018.0515.
- Background: PubMed 33911041Kwoen MJ, Choi YH, Kim KS, Chang NH, Kim YK, Lee HJ. Efficacy of local hyaluronidase administration in guided bone regeneration surgery: a randomized controlled trial. J Korean Assoc Oral Maxillofac Surg. 2021 Apr 30;47(2):91-98. doi: 10.5125/jkaoms.2021.47.2.91.
- Background: PubMed 39215323Koc O, Er N, Karaca C, Bilginaylar K. Comparison of the effects of submucosal hyaluronidase and dexamethasone on postoperative edema, pain, trismus, and infection following impacted third molar surgery. BMC Oral Health. 2024 Aug 30;24(1):1018. doi: 10.1186/s12903-024-04729-1.
- Background: PubMed 38109425Wang Q, Jin Q, Cai L, Zhao C, Feng P, Jia J, Xu W, Qian Q, Ding Z, Xu J, Gu C, Zhang S, Shi H, Ma H, Deng Y, Zhang T, Song Y, Wang Q, Zhang Y, Zhou X, Pei L, Yang Y, Liang J, Jiang T, Li H, Liu H, Wu L, Kang P. Efficacy of Diosmin in Reducing Lower-Extremity Swelling and Pain After Total Knee Arthroplasty: A Randomized, Controlled Multicenter Trial. J Bone Joint Surg Am. 2024 Mar 20;106(6):492-500. doi: 10.2106/JBJS.23.00854. Epub 2023 Dec 18.
- Clinical Research Information Service (CRIS) registration recordLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Berahyaluronidase alfa in people with Osteoarthritis, Knee and Postoperative Edema, run by Man Soo Kim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Composite Edema Index Based on Leg Circumference Measurements (time frame: Baseline, Postoperative Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07705165, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.