THE EFFECTIVENESS AND SAFETY OF SINGLE US GUIDED INJECTION OF HYLASTAN SGL-80 IN PRIMARY HIP OSTEOARTHRITIS. PRELIMINARY DATA FROM A PROSPECTIVE OBSERVATIONAL STUDY
MAHMOUD ALI A1, MASSIMIANI A2, CANTARELLA C3, FOTI C3
1Physical Medicine, Rheumatology and Rehabilitation Department, Ain Shams University, Cairo, Egypt, Doctorate School in Advanced Sciences and technologies in Rehabilitation Medicine and Sports, Tor Vergata University, Rome, Italy.
2Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy.
3Physical and Rehabilitation Medicine, Department of Clinical Sciences and Translational Medicine, Tor Vergata University, Rome, Italy.
Objective: To report preliminary data about the efficacy and safety of single intra-articular ultrasound guided injection of Hylastan SGL-80 in primary hip osteoarthritis of moderate severity. Materials and Methods: 20 patients (23 hip joints) were included. Each hip received single ultrasound guided injection of 4 ml Hylastan SGL-80 through a longitudinal antero-inferior approach. Hip examination, visual analogue scale (VAS), McGill Pain Questionnaire (McGill), Western Ontario McMaster Questionnaire (WOMAC), Lequesne Index, and tenderness scale were the main outcome measures for assessment of efficacy. Additionally both local and systemic side effect were screened through phone call 3 days after injection and regular follow up visits during the follow up duration: 1 month, 3 months, 6 months and 1 year post-injection. Results: 14 female (70%), 6 male patients (30%), mean age 68.4 years, mean Body Mass Index (BMI) 26.1 kg/m2, and average complaint duration 47.1 months. 23 hip joints were injected. Student-t test was used to compare baseline scales` values with those recorded after injection. 23 hips reached 1 month follow up, 22 reached 3 months, 17 reached 6 months, while 9 patients reached 1 year follow up. A significant improvement was shown at all time-points with (p<0.01) for all scales till T3, and continued till 1 year post-injection with (p<0.01) for WOMAC and (p<0.05) for McGill and Lequesne. The treatment was well tolerated by all patients without systemic adverse effects, only 2 hip joints reported mild localized pain that subsided spontaneously within 3 days post-injection. Conclusion: Our preliminary findings suggest that a single injection of Hylastan SGL-80 is safe and effective in patients with moderate primary hip osteoarthritis, and this effectiveness seems to be maintained over one year.
Vol. 3, no. 1, 3-13 (2014)