Knee OsteoarthritisPANDORA2NCT05978180

Safety of Use and Efficacy of Pandora for Patients Suffering From Gonarthrosis (PANDORA2)

A study testing Medical Device : HO-1, Medical Device : HS-3 and Medical Device : SINOVIAL® ONE in people with Knee Osteoarthritis, run by Labrha at 35 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies. Read more about this study

Who is it for?: Ages 35 to 85 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Medical Device : HO-1, Medical Device : HS-3 and Medical Device : SINOVIAL® ONE
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: 35 sitesin 2 countries
Study dates: 18 Oct 2023to 13 Nov 2025
Phase: Interventional
Are there results?: None posted in the registry

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 35 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Show all 23Show fewer

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.

Trial locations and contacts

35 sites in 2 countries.

Country

City, postcode or hospital

35 sites in 2 countries

France34 sites

Cabinet de Rhumatologie
Annecy
Centre de Chirurgie Orthopédique du Beaujolais
Arnas
Centre de Médecine du Sport du Beaujolais
Arnas
Cabinet de Rhumatologie
Bagnols-sur-Cèze
Cabinet de Rhumatologie La Savoureuse
Belfort
Hôpital Nord Franche Comté
Belfort
Cabinet de Rhumatologie de Palente
Besançon
Centre de Rhumatologie Nord Isère
Bourgoin
Cabinet de Rhumatologie
Castelnaudary
Polyclinique des Alpes du Sud
Gap
Cabinet de Rhumatologie
Gourdon
Centre Médical Dulac
La Ciotat
Cabinet Médical Tilsitt
Lyon
Centre Orthopédique Santy
Lyon
Clinique de la Sauvegarde
Lyon
Clinique Saint Charles
Lyon
Cabinet de Rhumatologie
Mâcon
Centre Médico-Social du Lac
Mantes-la-Jolie
Cabinet Médical Borely Mermoz
Marseille
Cabinet Médical
Montélimar
Groupe Médical Adhémar
Montélimar
Cabinet de Rhumatologie
Montpellier
Centre Médical Saint Roch
Montpellier
Cabinet Médical Pluridisciplinaire Wallach
Mulhouse
Cabinet de Rhumatologie
Nîmes
Clinique du Ter
Ploemeur
Cabinet Médical
Puyricard
Cabinet de Rhumatologie
Roanne
Cabinet Médical
Saint-Paul-lès-Dax
Groupe Médical Spécialisé - Le Premium
Strasbourg
Groupe Hospitalier de la Haute Saône - Hôpital de Vesoul
Vesoul
Cabinet de Rhumatologie
Villeurbanne
Cabinet de Rhumatologie
Viry-Châtillon
Pôle de santé des Sept Chemins
Vourles

Other trials in France

Monaco1 site

IM2S
Monaco

Other trials in Monaco

About this study

Official title: Prospective, Multicenter, Randomized, Parallel Groups Study Comparing the Safety and the Efficacy of the Administration of One Intra-articular Injection of 4.8 ml (HO-1) or Three Intra-articular Injections of 2.2 ml (HS-3) of Pandora Gel to One Intra-articular Injection of 2.5 ml (SINOVIAL®ONE), in Symptomatic Gonarthrosis

The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly.

The present clinical investigation has the objective to evaluate the safety and efficacy of use of Pandora, a hyaluronic acid associated with tranexamic acid, in a single injection (HO-1) or in three injections performed weekly (HS-3), compared to a referred and commercialized medical device.

Read the detailed description

This clinical investigation is a prospective, multicenter, randomized, parallel groups study of a class III Medical Device.

This study is designed to compare the safety of use and the efficacy of Pandora in its two forms : in a single injection (HO-1) or in three injections (HS-3) to a single intra-articular injection of 2.5 ml (SINOVIAL®ONE)

A descriptive analysis will be carried out to characterize the demographic data, the history of the disease and its treatments, the clinical and radiological data of the patients at inclusion.

The efficacy of Pandora will be demonstrated by describing the variation of WOMAC A1 score "walking pain" of target knee in repeated measures.

In total, 252 participants will be enrolled across 40 study centers in France and Monaco.

The total duration of subjects' participation is 12 months ; overall study duration including the enrollment period is expected to take approximately 24 months.

Conditions: Knee Osteoarthritis
Being tested: Medical Device : HO-1, Medical Device : HS-3, Medical Device : SINOVIAL® ONE
Keywords: Osteoarthritis, Viscosupplementation, Hyaluronic acid, Knee, Intra-articular injection, Tranexamic acid
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medical Device : HO-1Device
Also called Intra-articular single injection
The injection will be performed at Day 1.
Medical Device : HS-3Device
Also called Intra-articular three injections
The three injections will be performed at Days 1, 8 and 15.
Medical Device : SINOVIAL® ONEDevice
Also called Intra-articular single injection
The injection will be performed at Day 1.

Study groups in NCT05978180
Study group	Role	What they receive
Medical Device : HO-1	Experimental	Single injection Hyaluronic acid associated with tranexamic acid 4.8 ml will be injected in one time Intra-articular single injection * Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. * The injection will be performed at Day 1. Receives: Device: Medical Device : HO-1
Medical Device : HS-3	Experimental	Three injections Hyaluronic acid associated with tranexamic acid 2.2 ml will be injected in three times (one injection per week) Intra-articular single injection * Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. * The injections will be performed at Days 1, 8 and 15. Receives: Device: Medical Device : HS-3
Medical Device : SINOVIAL® ONE	Active comparator	Hyaluronic acid 2.5 ml will be injected in one time Intra-articular single injection * Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. * The injection will be performed at Day 1. Receives: Device: Medical Device : SINOVIAL® ONE

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the efficacy of the two medical devices containing Pandora gel, HO-1 and HS-3, on walking pain in the target knee, compared to the SINOVIAL® ONE.
Variation of the WOMAC A1 score "walking pain" of the target knee in repeated measures (weeks 4,12 and 26), between the first or single injection and the potential injection at week 26.
Measured: 6 months

Secondary outcomes (16)

To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on walking pain of the target knee between day 1 and week 12.
Variation of the WOMAC A1 score "walking pain" of the target knee between day 1 and week 12 considering the repeated measures at weeks 4 and 12.
Measured: 3 months
To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the pain of the target knee at weeks 4, 12 and 26 and week 12 as well as week 52 for patients who didn't require an injection at week 26.
Variation of the pain on target knee, with repeated measures by WOMAC A score, constituted of 5 questions about knee pain, between day 1 and week 12, day 1 and week 26 as well as between day 1 and week 52 for patients who didn't require an injection of HO-1 at week 26.
Measured: 12 months
To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the function of target knee at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26.
Variation of the function , with repeated measures by the WOMAC C constituted of 17 questions, between day 1 and week 4, day 1 and week 12, day 1 and week 26 as well as between day 1 and week 52 for patients who didn't require an injection at week 26.
Measured: 12 months
To evaluate the efficacy of viscosupplémentation by HO-1 and HS-3 on the analgesic drug consumption at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26.
Evaluation by the patient of his analgesic drug consumption during the two weeks prior each visit.
Measured: 12 months
To determine the number (and percentage) of patients "OMERACT-OARSI responsive" at weeks 4,12,26 as well as week 52 for patients who didn't require an injection at week 26.
Number (%) of "responsive" patients according to OMERACT OARSI criterion, at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26).
Measured: 12 months
To determine the number (and percentage) of "highly responsive" patients at weeks 4, 12 and 26 as well as week 52 for patients who didn't require an injection at week 26.
Number (%) of "highly responsive" patients with a decrease of WOMAC A1 > 50% at weeks 4, 12 and 26 (and week 52 for patients who didn't have HO-1 injection at S26).
Measured: 12 months
To determine the number (and percentage) of patients in whom target knee pain is considered acceptable according to the PASS criterion at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26.
Number (%) of patients reaching the threshold of PASS at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26).
Measured: 12 months
To determine the number (and percentage) of patients in whom the decrease of the target knee pain is considered important (MCII criterion) at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26.
Number (%) of patients whom the improvement at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26), is superior to the MCII.
Measured: 12 months
To determine the number (and percentage) of patients requiring a new injection at S26.
Number (%) of patients requiring an injection of HO-1 at week 26.
Measured: 6 months
To evaluate, at S52, the efficacy of the additional injection of HO-1 at S26 on pain and function of the target knee.
Variation of WOMAC between week 26 and week 52 at patients receiving injection of HO-1 at week 26.
Measured: 12 months
To evaluate, at S52, the benefit of the additional injection of HO-1 at S26 on analgesic drug consumption.
Decrease of analgesic drug consumption between week 26 and week 52 at patients receiving injection of HO-1 at week 26.
Measured: 12 months
To measure the self-reported treatment efficacy by the patient at weeks 4, 12, 26 and 52.
Evaluation of the efficacy of the treatment by the patient based on a 11 points numerical scale (0-10) at weeks 12,26 and 52.
Measured: 12 months
To evaluate the local tolerability (at the target knee), after each injection of HO-1 and HS-3, compared to SINOVIAL® ONE.
Number of adverse events occurring, at the target knee, after each injection during the 4 weeks following the first or only one injection, whose treatments causality is not evaluated as "not related".
Measured: 1 month
To evaluate the global tolerability of HO-1 and HS-3 throughout the follow-up between day 1 and week 52 in comparison with SINOVIAL® ONE.
Number of adverse events occurring during the 52 weeks of follow up, whose treatments causality is not evaluated as "not related".
Measured: 12 months
To assess patient's satisfaction regarding tolerability of HO-1 and HS-3 treatment between day 1 and week 4, compared to SINOVIAL® ONE.
Subjective assessment of tolerability by the patient, based on a 5 points numerical scale, 0 corresponding to "Very Good" and 4 "Very Bad" at day 8, day 15 and week 4 for group's patients HO-1 and SINOVIAL® ONE.
Measured: 1 month
To assess patient's satisfaction regarding the tolerability of HO-1 treatment at week 27 for patients who received an injection at week 26.
Subjective assessment of tolerability by the patient, based on a 5 points numerical scale, 0 corresponding to "Very Good" and 4 "Very Bad" at week 27 for patients receiving injection of HO-1 at week 26.
Measured: 6 months and one week (=27 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 202313 Nov 2025

First posted7 Aug 2023
Study start18 Oct 2023
Primary completion13 Nov 2025
Study completion13 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies 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: Prospective, multicenter, controlled, single blind, randomized in parallel groups Clinical Investigation. Subjects will receive one of three viscosupplementations depending on the randomization. The study includes two periods : * The first period (26 weeks) : prospective, multicenter, randomized in three parallel groups study, comparing the two forms of Pandora gel (HO-1 and HS-3) to SINOVIAL® ONE. The comparison between HO-1 and SINOVIAL® ONE is realized in single blind and the comparison between HS-3 and SINOVIAL® ONE is realized without masking. * The second period (26 weeks) is an exploratory, prospective, multicenter phase comparing these same devices without masking.
Masking: Single blind
Who is masked: Participant
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05978180
Sponsor's protocol ID: 2023-A00547-38
Acronym: PANDORA2
Status last verified: Dec 2025
First submitted: 28 Jul 2023
Last updated: 22 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sellam J, Courties A, Eymard F, Ferrero S, Latourte A, Ornetti P, Bannwarth B, Baumann L, Berenbaum F, Chevalier X, Ea HK, Fabre MC, Forestier R, Grange L, Lellouche H, Maillet J, Mainard D, Perrot S, Rannou F, Rat AC, Roux CH, Senbel E, Richette P; French Society of Rheumatology. Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis. Joint Bone Spine. 2020 Dec;87(6):548-555. doi: 10.1016/j.jbspin.2020.09.004. Epub 2020 Sep 12.
PubMed 32931933
Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89.
PubMed 15455338
Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2.
PubMed 29268731
Diracoglu D, Tuncay TB, Sahbaz T, Aksoy C. Single versus multiple dose hyaluronic acid: Comparison of the results. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):881-886. doi: 10.3233/BMR-160714.
PubMed 27257981
Bhadra AK, Altman R, Dasa V, Myrick K, Rosen J, Vad V, Vitanzo P Jr, Bruno M, Kleiner H, Just C. Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States. Cartilage. 2017 Jul;8(3):234-254. doi: 10.1177/1947603516662503. Epub 2016 Aug 10.
PubMed 28618868
Li J, Liu R, Rai S, Ze R, Tang X, Hong P. Intra-articular vs. intravenous administration: a meta-analysis of tranexamic acid in primary total knee arthroplasty. J Orthop Surg Res. 2020 Dec 2;15(1):581. doi: 10.1186/s13018-020-02119-1.
PubMed 33267906
Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.
PubMed 25797505
Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258.
PubMed 31800425

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Randomized, Parallel Groups Study Comparing the Safety and the Efficacy of the Administration of One Intra-articular Injection of 4.8 ml (HO-1) or Three Intra-articular Injections of 2.2 ml (HS-3) of Pandora Gel to One Intra-articular Injection of 2.5 ml (SINOVIAL®ONE), in Symptomatic Gonarthrosis
ClinicalTrials.gov ID: NCT05978180
Acronym / sponsor ID: PANDORA2 / 2023-A00547-38
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis, Viscosupplementation, Hyaluronic acid, Knee, Intra-articular injection, Tranexamic acid
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: LabrhaIndustry (pharma, biotech, devices)
Collaborators: Statitec
Study start: 18 Oct 2023 (actual)
Primary completion: 13 Nov 2025 (actual)
Study completion: 13 Nov 2025 (actual)
First posted: 7 Aug 2023 (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.

Detailed description

This clinical investigation is a prospective, multicenter, randomized, parallel groups study of a class III Medical Device.

A descriptive analysis will be carried out to characterize the demographic data, the history of the disease and its treatments, the clinical and radiological data of the patients at inclusion.

The efficacy of Pandora will be demonstrated by describing the variation of WOMAC A1 score "walking pain" of target knee in repeated measures.

In total, 252 participants will be enrolled across 40 study centers in France and Monaco.

The total duration of subjects' participation is 12 months ; overall study duration including the enrollment period is expected to take approximately 24 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: Prospective, multicenter, controlled, single blind, randomized in parallel groups Clinical Investigation. Subjects will receive one of three viscosupplementations depending on the randomization. The study includes two periods : * The first period (26 weeks) : prospective, multicenter, randomized in three parallel groups study, comparing the two forms of Pandora gel (HO-1 and HS-3) to SINOVIAL® ONE. The comparison between HO-1 and SINOVIAL® ONE is realized in single blind and the comparison between HS-3 and SINOVIAL® ONE is realized without masking. * The second period (26 weeks) is an exploratory, prospective, multicenter phase comparing these same devices without masking.

Arm	Type	Receives
Medical Device : HO-1	Experimental	Device: Medical Device : HO-1Single injection Hyaluronic acid associated with tranexamic acid 4.8 ml will be injected in one time Intra-articular single injection * Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. * The injection will be performed at Day 1.
Medical Device : HS-3	Experimental	Device: Medical Device : HS-3Three injections Hyaluronic acid associated with tranexamic acid 2.2 ml will be injected in three times (one injection per week) Intra-articular single injection * Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. * The injections will be performed at Days 1, 8 and 15.
Medical Device : SINOVIAL® ONE	Active comparator	Device: Medical Device : SINOVIAL® ONEHyaluronic acid 2.5 ml will be injected in one time Intra-articular single injection * Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. * The injection will be performed at Day 1.

Who may qualify

Ages: 35 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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).

Key exclusion criteria (23 listed)

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.

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
Medical Device : HO-1Also: Intra-articular single injectionThe injection will be performed at Day 1.	Device	Medical Device : HO-1
Medical Device : HS-3Also: Intra-articular three injectionsThe three injections will be performed at Days 1, 8 and 15.	Device	Medical Device : HS-3
Medical Device : SINOVIAL® ONEAlso: Intra-articular single injectionThe injection will be performed at Day 1.	Device	Medical Device : SINOVIAL® ONE

Primary outcome

To evaluate the efficacy of the two medical devices containing Pandora gel, HO-1 and HS-3, on walking pain in the target knee, compared to the SINOVIAL® ONE.
Time frame: 6 months
Variation of the WOMAC A1 score "walking pain" of the target knee in repeated measures (weeks 4,12 and 26), between the first or single injection and the potential injection at week 26.

16 secondary outcomes

To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on walking pain of the target knee between day 1 and week 12.
Time frame: 3 months
To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the pain of the target knee at weeks 4, 12 and 26 and week 12 as well as week 52 for patients who didn't require an injection at week 26.
Time frame: 12 months
To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the function of target knee at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26.
Time frame: 12 months
To evaluate the efficacy of viscosupplémentation by HO-1 and HS-3 on the analgesic drug consumption at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26.
Time frame: 12 months
To determine the number (and percentage) of patients "OMERACT-OARSI responsive" at weeks 4,12,26 as well as week 52 for patients who didn't require an injection at week 26.
Time frame: 12 months
To determine the number (and percentage) of "highly responsive" patients at weeks 4, 12 and 26 as well as week 52 for patients who didn't require an injection at week 26.
Time frame: 12 months
To determine the number (and percentage) of patients in whom target knee pain is considered acceptable according to the PASS criterion at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26.
Time frame: 12 months
To determine the number (and percentage) of patients in whom the decrease of the target knee pain is considered important (MCII criterion) at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26.
Time frame: 12 months
To determine the number (and percentage) of patients requiring a new injection at S26.
Time frame: 6 months
To evaluate, at S52, the efficacy of the additional injection of HO-1 at S26 on pain and function of the target knee.
Time frame: 12 months
To evaluate, at S52, the benefit of the additional injection of HO-1 at S26 on analgesic drug consumption.
Time frame: 12 months
To measure the self-reported treatment efficacy by the patient at weeks 4, 12, 26 and 52.
Time frame: 12 months
To evaluate the local tolerability (at the target knee), after each injection of HO-1 and HS-3, compared to SINOVIAL® ONE.
Time frame: 1 month
To evaluate the global tolerability of HO-1 and HS-3 throughout the follow-up between day 1 and week 52 in comparison with SINOVIAL® ONE.
Time frame: 12 months
To assess patient's satisfaction regarding tolerability of HO-1 and HS-3 treatment between day 1 and week 4, compared to SINOVIAL® ONE.
Time frame: 1 month
To assess patient's satisfaction regarding the tolerability of HO-1 treatment at week 27 for patients who received an injection at week 26.
Time frame: 6 months and one week (=27 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
Background: PubMed 32931933Sellam J, Courties A, Eymard F, Ferrero S, Latourte A, Ornetti P, Bannwarth B, Baumann L, Berenbaum F, Chevalier X, Ea HK, Fabre MC, Forestier R, Grange L, Lellouche H, Maillet J, Mainard D, Perrot S, Rannou F, Rat AC, Roux CH, Senbel E, Richette P; French Society of Rheumatology. Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis. Joint Bone Spine. 2020 Dec;87(6):548-555. doi: 10.1016/j.jbspin.2020.09.004. Epub 2020 Sep 12.
Background: PubMed 15455338Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89.
Background: PubMed 29268731Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2.
Background: PubMed 27257981Diracoglu D, Tuncay TB, Sahbaz T, Aksoy C. Single versus multiple dose hyaluronic acid: Comparison of the results. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):881-886. doi: 10.3233/BMR-160714.
Background: PubMed 28618868Bhadra AK, Altman R, Dasa V, Myrick K, Rosen J, Vad V, Vitanzo P Jr, Bruno M, Kleiner H, Just C. Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States. Cartilage. 2017 Jul;8(3):234-254. doi: 10.1177/1947603516662503. Epub 2016 Aug 10.
Background: PubMed 33267906Li J, Liu R, Rai S, Ze R, Tang X, Hong P. Intra-articular vs. intravenous administration: a meta-analysis of tranexamic acid in primary total knee arthroplasty. J Orthop Surg Res. 2020 Dec 2;15(1):581. doi: 10.1186/s13018-020-02119-1.
Background: PubMed 25797505Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.
Background: PubMed 31800425Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258.
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. This study is not recruiting at the moment.

Patrick Sac-Epee study director

Labrha

Jean-Charles Balblanc, Dr principal investigator

Hôpital Nord Franche-Comté, HNFC

35 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medical Device : HO-1, Medical Device : HS-3 and Medical Device : SINOVIAL® ONE in people with Knee Osteoarthritis, run by Labrha at 35 sites in 2 countries.

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 10 inclusion and 23 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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the efficacy of the two medical devices containing Pandora gel, HO-1 and HS-3, on walking pain in the target knee, compared to the SINOVIAL® ONE. (time frame: 6 months). 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 NCT05978180, which also lists 8 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 22 Dec 2025.