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

NCT05978180 | Completed DMC

• 1 other identifier: 2023-A00547-38
• Study Type: interventional
• Target: 252
• Locations: 2 countries
• Sites: 35

Brief 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. 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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Viscosupplementation; Hyaluronic acid; Knee; Intra-articular injection; Tranexamic acid

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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.

  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.

  12 months

Study Arms (3)

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.

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.

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.

Device: Medical Device : SINOVIAL® ONE

Interventions

Medical Device : HO-1 DEVICE

The injection will be performed at Day 1.

Also known as: Intra-articular single injection

Medical Device : HO-1

Medical Device : HS-3 DEVICE

The three injections will be performed at Days 1, 8 and 15.

Also known as: Intra-articular three injections

Medical Device : HS-3

Medical Device : SINOVIAL® ONE DEVICE

The injection will be performed at Day 1.

Also known as: Intra-articular single injection

Medical Device : SINOVIAL® ONE

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• Patient with hypersensitivity to hyaluronic acid or tranexamic acid.
• Patient with a history of seizures.
• 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.

Sponsors & Collaborators

• Labrha: lead
• Statitec: collaborator

Study Sites (35)

Cabinet de Rhumatologie

Annecy, France

Location

Centre de Chirurgie Orthopédique du Beaujolais

Arnas, France

Location

Centre de Médecine du Sport du Beaujolais

Arnas, France

Location

Cabinet de Rhumatologie

Bagnols-sur-Cèze, France

Location

Cabinet de Rhumatologie La Savoureuse

Belfort, France

Location

Hôpital Nord Franche Comté

Belfort, France

Location

Cabinet de Rhumatologie de Palente

Besançon, France

Location

Centre de Rhumatologie Nord Isère

Bourgoin, France

Location

Cabinet de Rhumatologie

Castelnaudary, France

Location

Polyclinique des Alpes du Sud

Gap, France

Location

Cabinet de Rhumatologie

Gourdon, France

Location

Centre Médical Dulac

La Ciotat, France

Location

Cabinet Médical Tilsitt

Lyon, France

Location

Centre Orthopédique Santy

Lyon, France

Location

Clinique de la Sauvegarde

Lyon, France

Location

Clinique Saint Charles

Lyon, France

Location

Centre Médico-Social du Lac

Mantes-la-Jolie, France

Location

Cabinet Médical Borely Mermoz

Marseille, France

Location

Cabinet de Rhumatologie

Mâcon, France

Location

Cabinet Médical

Montélimar, France

Location

Groupe Médical Adhémar

Montélimar, France

Location

Cabinet de Rhumatologie

Montpellier, France

Location

Centre Médical Saint Roch

Montpellier, France

Location

Cabinet Médical Pluridisciplinaire Wallach

Mulhouse, France

Location

Cabinet de Rhumatologie

Nîmes, France

Location

Clinique du Ter

Ploemeur, France

Location

Cabinet Médical

Puyricard, France

Location

Cabinet de Rhumatologie

Roanne, France

Location

Cabinet Médical

Saint-Paul-lès-Dax, France

Location

Groupe Médical Spécialisé - Le Premium

Strasbourg, France

Location

Groupe Hospitalier de la Haute Saône - Hôpital de Vesoul

Vesoul, France

Location

Cabinet de Rhumatologie

Villeurbanne, France

Location

Cabinet de Rhumatologie

Viry-Châtillon, France

Location

Pôle de santé des Sept Chemins

Vourles, France

Location

IM2S

Monaco, Monaco

Location

Related Publications (8)

• 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.

  PMID: 32931933 BACKGROUND

• Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89.

  PMID: 15455338 BACKGROUND

• 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.

  PMID: 29268731 BACKGROUND

• 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.

  PMID: 27257981 BACKGROUND

• 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.

  PMID: 28618868 BACKGROUND

• 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.

  PMID: 33267906 BACKGROUND

• 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.

  PMID: 25797505 BACKGROUND

• 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.

  PMID: 31800425 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Injections

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Patrick Sac-Epee

  Labrha

  STUDY DIRECTOR

• Jean-Charles Balblanc, Dr

  Hôpital Nord Franche-Comté, HNFC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: October 18, 2023
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (34); MO (1)