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

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medical Device : HO-1
Medical Device : HS-3
Medical Device : SINOVIAL® ONE
Sponsored by
Labrha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Viscosupplementation, Hyaluronic acid, Knee, Intra-articular injection, Tranexamic acid

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre de Recherche Rhumatologique et Thermal
  • Cabinet de Rhumatologie
  • Clinique d'Arnogay
  • Cabinet de Rhumatologie
  • Cabinet de Rhumatologie La Savoureuse
  • Hôpital Nord Franche Comté
  • Cabinet de Rhumatologie de Palente
  • Cabinet de Rhumatologie
  • Cabinet de Rhumatologie de Cornebarrieu
  • Polyclinique des Alpes du Sud
  • Cabinet de Rhumatologie
  • Centre Médical Dulac
  • Cabinet Médical
  • Cabinet de Rhumatologie
  • Cabinet Médical Tilsitt
  • Centre Orthopédique Paul Santy
  • Clinique de la Sauvegarde
  • Clinique Saint Charles
  • Centre Médico-Social du Lac
  • Cabinet Médical Borely Mermoz
  • Hôpital Lozère
  • Cabinet de Rhumatologie
  • Centre Médical Saint Roch
  • Cabinet Médical
  • Groupe Médical Adhémar
  • Cabinet de Rhumatologie
  • Cabinet Médical Pluridisciplinaire Wallach
  • Cabinet de Rhumatologie
  • Cabinet Médical Maillot
  • Cabinet de Rhumatologie
  • Cabinet de Rhumatologie
  • Clinique du Ter
  • Cabinet Médical
  • Cabinet Médical
  • Groupe Médical Spécialisé - Le Premium
  • Groupe Hospitalier de la Haute Saône - Hôpital de Vesoul
  • Cabinet de Rhumatologie
  • Cabinet de Rhumatologie
  • IM2S

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Medical Device : HO-1

Medical Device : HS-3

Medical Device : SINOVIAL® ONE

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
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".
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".
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.
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.

Full Information

First Posted
July 28, 2023
Last Updated
October 12, 2023
Sponsor
Labrha
Collaborators
Statitec
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1. Study Identification

Unique Protocol Identification Number
NCT05978180
Brief Title
Safety of Use and Efficacy of Pandora for Patients Suffering From Gonarthrosis (PANDORA2)
Acronym
PANDORA2
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 16, 2023 (Anticipated)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Labrha
Collaborators
Statitec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Viscosupplementation, Hyaluronic acid, Knee, Intra-articular injection, Tranexamic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Single blind
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical Device : HO-1
Arm Type
Experimental
Arm Description
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.
Arm Title
Medical Device : HS-3
Arm Type
Experimental
Arm Description
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.
Arm Title
Medical Device : SINOVIAL® ONE
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Medical Device : HO-1
Other Intervention Name(s)
Intra-articular single injection
Intervention Description
The injection will be performed at Day 1.
Intervention Type
Device
Intervention Name(s)
Medical Device : HS-3
Other Intervention Name(s)
Intra-articular three injections
Intervention Description
The three injections will be performed at Days 1, 8 and 15.
Intervention Type
Device
Intervention Name(s)
Medical Device : SINOVIAL® ONE
Other Intervention Name(s)
Intra-articular single injection
Intervention Description
The injection will be performed at Day 1.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 months
Title
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.
Description
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.
Time Frame
12 months
Title
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.
Description
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.
Time Frame
12 months
Title
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.
Description
Evaluation by the patient of his analgesic drug consumption during the two weeks prior each visit.
Time Frame
12 months
Title
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.
Description
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).
Time Frame
12 months
Title
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.
Description
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).
Time Frame
12 months
Title
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.
Description
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).
Time Frame
12 months
Title
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.
Description
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.
Time Frame
12 months
Title
To determine the number (and percentage) of patients requiring a new injection at S26.
Description
Number (%) of patients requiring an injection of HO-1 at week 26.
Time Frame
6 months
Title
To evaluate, at S52, the efficacy of the additional injection of HO-1 at S26 on pain and function of the target knee.
Description
Variation of WOMAC between week 26 and week 52 at patients receiving injection of HO-1 at week 26.
Time Frame
12 months
Title
To evaluate, at S52, the benefit of the additional injection of HO-1 at S26 on analgesic drug consumption.
Description
Decrease of analgesic drug consumption between week 26 and week 52 at patients receiving injection of HO-1 at week 26.
Time Frame
12 months
Title
To measure the self-reported treatment efficacy by the patient at weeks 4, 12, 26 and 52.
Description
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.
Time Frame
12 months
Title
To evaluate the local tolerability (at the target knee), after each injection of HO-1 and HS-3, compared to SINOVIAL® ONE.
Description
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".
Time Frame
1 month
Title
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.
Description
Number of adverse events occurring during the 52 weeks of follow up, whose treatments causality is not evaluated as "not related".
Time Frame
12 months
Title
To assess patient's satisfaction regarding tolerability of HO-1 and HS-3 treatment between day 1 and week 4, compared to SINOVIAL® ONE.
Description
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.
Time Frame
1 month
Title
To assess patient's satisfaction regarding the tolerability of HO-1 treatment at week 27 for patients who received an injection at week 26.
Description
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.
Time Frame
6 months and one week (=27 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie Genet
Phone
06 82 29 36 07
Ext
33
Email
leslie.genet@labrha.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry Conrozier, Dr
Phone
03 84 98 22 22
Ext
33
Email
thierry.conrozier@hnfc.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Sac-Epee
Organizational Affiliation
Labrha
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean-Charles Balblanc, Dr
Organizational Affiliation
Hôpital Nord Franche-Comté, HNFC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche Rhumatologique et Thermal
City
Aix-les-Bains
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Forestier, Dr
Facility Name
Cabinet de Rhumatologie
City
Annecy
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu Monreal, Dr
Facility Name
Clinique d'Arnogay
City
Argonay
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Le Masle Lastiolas, Dr
Facility Name
Cabinet de Rhumatologie
City
Auch
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme Porterie, Dr
Facility Name
Cabinet de Rhumatologie La Savoureuse
City
Belfort
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Bossert, Dr
Facility Name
Hôpital Nord Franche Comté
City
Belfort
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Balblanc, Dr
Facility Name
Cabinet de Rhumatologie de Palente
City
Besançon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit Auge, Dr
Facility Name
Cabinet de Rhumatologie
City
Castelnaudary
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Hacene-Beniddir, Dr
Facility Name
Cabinet de Rhumatologie de Cornebarrieu
City
Cornebarrieu
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Huyghe-Valean, Dr
Facility Name
Polyclinique des Alpes du Sud
City
Gap
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Prothoy, Dr
Facility Name
Cabinet de Rhumatologie
City
Gourdon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Imart, Dr
Facility Name
Centre Médical Dulac
City
La Ciotat
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Steib, Dr
Facility Name
Cabinet Médical
City
La Crau
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Fulpin, Dr
Facility Name
Cabinet de Rhumatologie
City
La Tour-du-Pin
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Sornay-Rendu, Dr
Facility Name
Cabinet Médical Tilsitt
City
Lyon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Nectoux, Dr
Facility Name
Centre Orthopédique Paul Santy
City
Lyon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte Rey, Dr
Facility Name
Clinique de la Sauvegarde
City
Lyon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaut Rolland, Dr
Facility Name
Clinique Saint Charles
City
Lyon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Malterre, Dr
Facility Name
Centre Médico-Social du Lac
City
Mantes-la-Jolie
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Renevier, Dr
Facility Name
Cabinet Médical Borely Mermoz
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Lecurieux-Clerville, Dr
Facility Name
Hôpital Lozère
City
Mende
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raluca Angelescu-Prunel, Dr
Facility Name
Cabinet de Rhumatologie
City
Montpellier
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Françoise Roch-Bras, Dr
Facility Name
Centre Médical Saint Roch
City
Montpellier
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Ferrazzi, Dr
Facility Name
Cabinet Médical
City
Montélimar
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Kandil, Dr
Facility Name
Groupe Médical Adhémar
City
Montélimar
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Despaux, Dr
Facility Name
Cabinet de Rhumatologie
City
Mulhouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naji Afif, Dr
Facility Name
Cabinet Médical Pluridisciplinaire Wallach
City
Mulhouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime Sondag, Dr
Facility Name
Cabinet de Rhumatologie
City
Mâcon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Mohnen, Dr
Facility Name
Cabinet Médical Maillot
City
Neuilly-sur-Seine
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Gepner, Dr
Facility Name
Cabinet de Rhumatologie
City
Nîmes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Guilyardi, Dr
Facility Name
Cabinet de Rhumatologie
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé Bard, Dr
Facility Name
Clinique du Ter
City
Ploemeur
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amrane Hadj Hamou, Dr
Facility Name
Cabinet Médical
City
Puyricard
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Melchior, Dr
Facility Name
Cabinet Médical
City
Saint-Paul-lès-Dax
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danièle Prothery, Dr
Facility Name
Groupe Médical Spécialisé - Le Premium
City
Strasbourg
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Dahan, Dr
Facility Name
Groupe Hospitalier de la Haute Saône - Hôpital de Vesoul
City
Vesoul
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violette Benier, Dr
Facility Name
Cabinet de Rhumatologie
City
Villeurbanne
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal Benabdesselam, Dr
Facility Name
Cabinet de Rhumatologie
City
Viry-Châtillon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Sebaa, Dr
Facility Name
IM2S
City
Monaco
Country
Monaco
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Parisaux, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32931933
Citation
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.
Results Reference
background
PubMed Identifier
15455338
Citation
Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89.
Results Reference
background
PubMed Identifier
29268731
Citation
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.
Results Reference
background
PubMed Identifier
27257981
Citation
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.
Results Reference
background
PubMed Identifier
28618868
Citation
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.
Results Reference
background
PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
25797505
Citation
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.
Results Reference
background
PubMed Identifier
31800425
Citation
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.
Results Reference
background

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

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