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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-18

Study Completion Date

2025-11-13

Brief Summary

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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.

Detailed Description

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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

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Knee Osteoarthritis

Keywords

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Osteoarthritis Viscosupplementation Hyaluronic acid Knee Intra-articular injection Tranexamic acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single blind

Study Groups

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Medical Device : HO-1

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.

Group Type EXPERIMENTAL

Medical Device : HO-1

Intervention Type DEVICE

The injection will be performed at Day 1.

Medical Device : HS-3

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.

Group Type EXPERIMENTAL

Medical Device : HS-3

Intervention Type DEVICE

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

Medical Device : SINOVIAL® ONE

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.

Group Type ACTIVE_COMPARATOR

Medical Device : SINOVIAL® ONE

Intervention Type DEVICE

The injection will be performed at Day 1.

Interventions

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Medical Device : HO-1

The injection will be performed at Day 1.

Intervention Type DEVICE

Medical Device : HS-3

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

Intervention Type DEVICE

Medical Device : SINOVIAL® ONE

The injection will be performed at Day 1.

Intervention Type DEVICE

Other Intervention Names

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Intra-articular single injection Intra-articular three injections Intra-articular single injection

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Sac-Epee

Role: STUDY_DIRECTOR

Labrha

Jean-Charles Balblanc, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Nord Franche-Comté, HNFC

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France Monaco

Reference Type BACKGROUND

PMID: 31800425 (View on PubMed)

Other Identifiers

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2023-A00547-38

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Medical Device : HO-1

Medical Device : HO-1

Medical Device : HS-3

Medical Device : HS-3

Medical Device : SINOVIAL® ONE

Medical Device : SINOVIAL® ONE

Interventions

Medical Device : HO-1

Medical Device : HS-3

Medical Device : SINOVIAL® ONE

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Statitec

Labrha

Responsible Party

Principal Investigators

Patrick Sac-Epee

Jean-Charles Balblanc, Dr

Locations

Cabinet de Rhumatologie

Centre de Chirurgie Orthopédique du Beaujolais

Centre de Médecine du Sport du Beaujolais

Cabinet de Rhumatologie

Cabinet de Rhumatologie La Savoureuse

Hôpital Nord Franche Comté

Cabinet de Rhumatologie de Palente

Centre de Rhumatologie Nord Isère

Cabinet de Rhumatologie

Polyclinique des Alpes du Sud

Cabinet de Rhumatologie

Centre Médical Dulac

Cabinet Médical Tilsitt

Centre Orthopédique Santy

Clinique de la Sauvegarde

Clinique Saint Charles

Centre Médico-Social du Lac

Cabinet Médical Borely Mermoz

Cabinet de Rhumatologie

Cabinet Médical

Groupe Médical Adhémar

Cabinet de Rhumatologie

Centre Médical Saint Roch

Cabinet Médical Pluridisciplinaire Wallach

Cabinet de Rhumatologie

Clinique du Ter

Cabinet Médical

Cabinet de Rhumatologie

Cabinet Médical

Groupe Médical Spécialisé - Le Premium

Groupe Hospitalier de la Haute Saône - Hôpital de Vesoul

Cabinet de Rhumatologie

Cabinet de Rhumatologie

Pôle de santé des Sept Chemins

IM2S

Countries

References

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

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.

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.

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.

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.

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.

Other Identifiers

2023-A00547-38