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Could a single injection after knee surgery cut swelling in half?

NCT ID NCT07705165

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial tests whether an injection of tergase (berahyaluronidase alfa) can reduce swelling after total knee replacement surgery. The study involves 30 older adults with severe knee osteoarthritis who are having both knees replaced at the same time. One knee receives the injection right after surgery, while the other knee serves as an untreated comparison. Researchers measure leg swelling at several points over three months to see if the treated knee has less fluid buildup.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an injection of berahyaluronidase alfa (tergase) given under the skin around the surgical wound
What this could lead to
If it works, this could offer a way to reduce painful swelling and speed recovery after knee replacement surgery.
What could go wrong
This is a small, early-stage trial with only 30 people, so results may not apply to everyone. The injection is given right after surgery, and there may be unknown side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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More trials for these conditions

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