Author: Thierry Conrozier*, Matthieu Monet, Ana-Maria Bozgan
Published: March 24, 2017
DOI: 10.19080/OROAJ.2017.05.555664
Abstract Content: Objectives: To Assess, In Daily Practice Conditions, Both Safety And Efficacy Of A Single Intra-articular Injection Of A Cross-linked Hyaluronic Acid (HA) Combined With Mannitol (HANOX-M-XL) In Patients With Symptomatic Knee Osteoarthritis. Methods: We Analyzed The Clinical And Radiological Data Of 53 Consecutive Patients With Symptomatic Knee OA, Treated Between January And June 2016 With A Single Intra-articular Injection Of HANOX-M-XL, A Viscosupplement Made Of A Cross-linked HA (16 Mg/ml) + Mannitol (35 Mg/ml). The Efficacy Endpoints Included The Changes Over Time In The Normalized (0-10) WOMAC Pain, Function And Total And The Patient’s Global Assessment (PGA). Patient Acceptable Symptom State (PASS) And Minimum Clinically Important Improvement (MCII) Were Calculated From WOMAC Pain Sub-score. Patient’s Self Assessment Of Treatment Efficacy (0-3) And The Decrease In Analgesic Consumption (0-5) Were Also Obtained At The End Of Follow-up. Safety Was Assessed By Recording All Adverse Events. Results: During The Selected Period Of Time 53 Patients With Knee OA Were Treated With HANOX-M-XL. The Mean Follow-up Duration Was 28 Weeks (18 To 32). No Patient Was Lost To Follow-up. At Baseline The Mean WOMAC Pain Sub-score And PGA Were 4.6 (1.2) And 6.0 (1.1) Respectively. The Average Decrease Of WOMAC Score Over The 6 Month Follow-up Was > 50%, Versus Baseline Values, For Both Pain And Function (P<0.0001). At Month 6, 82% Of Patients Were PASS + And 86.8% Had Experienced Improvement > MCII Threshold. Three Patients Experienced Local Adverse Events (increase Of Knee Pain) After Injection That Resolved Within 3 Days. Conclusion: In Daily Practice Conditions, Treatment With A Single IA Injection Of HAnox-M-XL Alleviates By More Than 50% Knee OA Symptoms, Over 6 Months, In A Large Majority Of Patients, Without Safety Concern.
November 09, 2021
by Yoshiyuki Sasano*
Pages: 5
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