Safety of Use of Pandora for Patients Suffering From Gonarthrosis

NCT05414617 | Completed DMC

• 1 other identifier: 2021-A01153-38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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 of use of Pandora in a single injection or in three injections performed weekly.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number of adverse event attributable to the investigational Medical Device during the week following each injection.

  Adverse events will be collected at : * Day 8 for Happyone arm (single injection) ; * Days 8, 15 and 22 for Happysoft arm (three injections).

  1 month

Secondary Outcomes (4)

• Number of adverse events during the month following the first injection for immediate and delayed local tolerance evaluation.

  1 month

• Patient self-assesment of the overall tolerance of the treatment based on a 5-point scale, from "Very bad" to "Very good".

  1 month

• Variation over time of the WOMAC score, between time of injection and end point, and the WOMAC subscores A (pain) and C (function). The WOMAC-Questionnaire is based on a 11 points scale, from 0 = None to 10 = Extreme.

  6 months

• Patient self-assesment of the effectiveness of the treatment based on a 11 points numeric scale, from 0 = None to 10 = Total.

  6 months

Study Arms (2)

Medical Device : Happyone

EXPERIMENTAL

Hyaluronic acid associated with tranexamic acid ; 4.8 ml will be injected in one time

Device: Intra-articular single injection

Medical Device : Happysoft

EXPERIMENTAL

Hyaluronic acid associated with tranexamic acid ; 2.2 ml will be injected in three times (one injection per week)

Device: Intra-articular three injections

Interventions

Intra-articular single injection DEVICE

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 : Happyone

Intra-articular three injections DEVICE

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 : Happysoft

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) \< 30 kg.m\^2.
• 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 12 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).
• Ambulatory patient able to walk 50 meters without a cane, crutch or walker.
• Patient able to read, understand, sign and date the patient information sheet.
• Patient agreeing to follow-up study visits.
• Patient affiliated to the health social security system.
• 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).
• Walking pain in the target knee, rated less than 4 or more than 8 on an 11-point numerical scale (0 = none to 10 = extreme).
• Patient with a flare of osteoarthritis of the target or contralateral knee attested by KOFUS criteria ≥ 7.
• 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) that could interfere with the measurement of the effectiveness of the treatment of the knee evaluated.
• Patient with 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 an evolving general cardiac, digestive, endocrine, haematological or broncho-pulmonary condition which, in the opinion of the investigator, would be likely to disrupt regular monitoring and/or interfere with the measurement of treatment efficacy .
• Breastfeeding patient, pregnant or wishing to be during the 6 months of the study.
• Patient unable to give personal consent.
• Patient with renal insufficiency.

Sponsors & Collaborators

• Labrha: lead
• Statitec: collaborator

Study Sites (2)

Hôpital Nord Franche-Comté, HNFC

Belfort, France

Location

Groupe Hospitalier de la Région Mulhouse Sud-Alsace, GHRMSA

Mulhouse, France

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

Interventions

Injections

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jean-Charles Balblanc, MD

  Hôpital Nord Franche-Comté, HNFC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Multi-center, Open Clinical Investigation. Two facilities are participating ; each facility will be in charge and perform a type of viscosupplementation procedure : single injection or three injections. Subjects will received one or the other viscosupplementation depending of the facility in which they will be included.

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 10, 2022
• Study Start: June 8, 2022
• Primary Completion: January 18, 2023
• Study Completion: June 14, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)