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New gel injection could ease knee pain for months

NCT ID NCT05978180

Symptom relief Sponsor: Labrha Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a gel called Pandora, made of hyaluronic acid and tranexamic acid, injected into the knee to reduce pain and improve movement in people with knee osteoarthritis. 252 adults aged 35–85 with moderate knee arthritis received either one injection, three weekly injections of Pandora gel, or a standard single injection of a similar product. The goal was to see which approach works best for walking pain over 6 months.

What this could mean

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

Active substance
Pandora gel (hyaluronic acid with tranexamic acid)
What this could lead to
If it works, this could offer a more effective or longer-lasting option for reducing knee pain and improving mobility in people with knee osteoarthritis.
What could go wrong
This is a completed trial comparing different injection schedules, not a new breakthrough. The gel is similar to existing treatments, so major improvements are unlikely. Results may not apply to all patients.

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

252 people

The number who actually took part.

Started

Oct 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

35 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 : * Patient aged between 35 and 85 years. * Body mass index (BMI) \< 35 kg.m2. * Medial or lateral femoro-tibial knee osteoarthritis, diagnosed according to the American College of Rheumatology criteria, radiological stage 2 and 3 according to the Kellgren-Lawrence criteria modified by Felson on an X-ray, of the knee in extension, less than 6 months old. * Knee osteoarthritis responsible for walking pain in the target knee, assessed between 4 and 8 inclusive on an 11 points numerical scale (0 = none to 10 = extreme). * Unilateral or bilateral knee osteoarthritis if the walking pain in the contralateral knee is \< 3 based on 11 points numerical scale (0-10). * Ambulatory patient able to walk 50 meters without a cane, crutch or walker. * Patient giving his informed consent. * Patient agreeing to follow-up study visits. * Patient affiliated to the health social security system or beneficiary of such plan. * Patient requiring viscosupplementation according to the investigator. Exclusion Criteria : * Patient presenting knee osteoarthritis without impingement joint space narrowing of the femoro-tibial compartment (modified Kellgren stage 0-1) or with complete impingement joint space narrowing on the knee weight-bearing radiograph in extension (modified Kellgren stage 4). * Patient with bilateral symptomatic gonarthrosis with walking pain of contralateral knee \> 3. * Patient with stage 4 patello-femoral osteoarthritis associated with femoro-tibial osteoarthritis. * Patient with a flare of osteoarthritis of the target or contralateral knee. * Patient who received viscosupplementation or Platelet Rich Plasma (PRP) injection, in the target knee, in the 6 months prior to inclusion. * Patient who received an intra-articular injection of corticosteroids in the target knee in the 2 months prior to inclusion. * Patients with a skin condition or a wound next to or near the injection site. * Patients refusing to discontinue treatment with NSAIDs or cox-2 inhibitors during the follow-up period. * Patient receiving treatment with level III analgesics (strong opioids). * Patients receiving treatment with diacerhein, avocado and soy unsaponifiables, glucosamine or chondroitin initiated less than 2 months prior to inclusion. * Patient with hypersensitivity to hyaluronic acid or tranexamic acid. * Patient with a history of seizures. * Patient who had arthroscopy of the target knee or major trauma to the target knee during the 3 months preceding inclusion. * Patient scheduled to undergo surgery, for any cause, of the target knee or other joint of the lower limbs, planned within 6 months of inclusion, likely to interfere with follow-up or evaluation of the patient in the study. * Patient with Fibromyalgia. * Patient with an active neurological or vascular musculoskeletal disorder (such as rheumatoid arthritis, lupus, psoriatic arthritis, spondyloarthritis or any other autoimmune disease, Paget's disease, gout, coxopathy, tendinopathy of the lower limb, sciatic or crural radiculalgia) which, in the opinion of the investigator, would be likely to disrupt regular monitoring and/or interfere with the measurement of evaluated knee treatment efficacy. * Patient with serious hemostasis disorders, venous or lymphatic stenosis of the lower limbs, history of thromboembolic disease - phlebitis or pulmonary embolism - or a high risk of thromboembolism. * Patients with renal insufficiency. * Patients with all evolving general condition as cardiac, digestive, endocrine, haematological or broncho-pulmonary which, in the opinion of the investigator, would be likely to disrupt regular monitoring and/or interfere with the measurement of evaluated knee treatment efficacy. * Breastfeeding patient, pregnant or wishing to be during the 12 months of the study. * Patients of childbearing age, sexually active without contraception. * Patients unable to give personal consent. * Patients participating or having participated in interventional research and whose follow-up ended within 2 months prior to inclusion.

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

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

Knee osteoarthritis

Contacts and locations

Locations

  • Cabinet Médical

    Montélimar, France

  • Cabinet Médical

    Puyricard, France

  • Cabinet Médical

    Saint-Paul-lès-Dax, France

  • Cabinet Médical Borely Mermoz

    Marseille, France

  • Cabinet Médical Pluridisciplinaire Wallach

    Mulhouse, France

  • Cabinet Médical Tilsitt

    Lyon, France

  • Cabinet de Rhumatologie

    Annecy, France

  • Cabinet de Rhumatologie

    Bagnols-sur-Cèze, France

  • Cabinet de Rhumatologie

    Castelnaudary, France

  • Cabinet de Rhumatologie

    Gourdon, France

  • Cabinet de Rhumatologie

    Mâcon, France

  • Cabinet de Rhumatologie

    Montpellier, France

  • Cabinet de Rhumatologie

    Nîmes, France

  • Cabinet de Rhumatologie

    Roanne, France

  • Cabinet de Rhumatologie

    Villeurbanne, France

  • Cabinet de Rhumatologie

    Viry-Châtillon, France

  • Cabinet de Rhumatologie La Savoureuse

    Belfort, France

  • Cabinet de Rhumatologie de Palente

    Besançon, France

  • Centre Médical Dulac

    La Ciotat, France

  • Centre Médical Saint Roch

    Montpellier, France

  • Centre Médico-Social du Lac

    Mantes-la-Jolie, France

  • Centre Orthopédique Santy

    Lyon, France

  • Centre de Chirurgie Orthopédique du Beaujolais

    Arnas, France

  • Centre de Médecine du Sport du Beaujolais

    Arnas, France

  • Centre de Rhumatologie Nord Isère

    Bourgoin, France

  • Clinique Saint Charles

    Lyon, France

  • Clinique de la Sauvegarde

    Lyon, France

  • Clinique du Ter

    Ploemeur, France

  • Groupe Hospitalier de la Haute Saône - Hôpital de Vesoul

    Vesoul, France

  • Groupe Médical Adhémar

    Montélimar, France

  • Groupe Médical Spécialisé - Le Premium

    Strasbourg, France

  • Hôpital Nord Franche Comté

    Belfort, France

  • IM2S

    Monaco, Monaco

  • Polyclinique des Alpes du Sud

    Gap, France

  • Pôle de santé des Sept Chemins

    Vourles, France

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