Standardized Follow-up of Patients with Symptomatic Knee Osteoarthritis Treated with a Single Intra-articular Injection of a Combination of Cross-Linked Hyaluronic Acid and Mannitol. T. Conrozier, AM. Bozgan, M. Bossert, M. Sondag, A. Lohse-Walliser and JC. Balblanc.Clin Med Insights Arthritis Musculoskelet Disord. 2016 Sep 25;9:175-9. doi: 10.4137/CMAMD.S39432
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The above mentioned study has been conducted by LABRHA to obtain pilot data from daily practice conditions of HAppyCross® (HANOX-M-XL) in patients with knee osteoarthritis (KOA). All patients have received a single intra-articular injection of 4.4ml of HAppyCross®, a viscosupplement made of a cross-linked HA (16 mg/mL) + mannitol (35 mg/mL), in the target knee.
The primary outcome was safety, to demonstrate that 4.4 ml is well-tolerated in the knees.
The secondary end point was pain relief over 6 months.
This study shows that:
- 4.4 ml of HAppyCross® can be used without safety concerns. Indeed, tolerability of HAppyCross® was absolutely similar to that of regular viscosupplements not containing mannitol, demonstrating that the addition of mannitol to HA does not modify the local or general tolerability of viscosupplementation.
- 4.4 ml of HAppyCross® allows a long-lasting pain relief and a significant decrease of analgesic consumption.
- In case of Grade IV OA, 4.4ml of HAppyCross® is effective and ensures a pain relief over 6 months. No other studies have demonstrated this so far for a 6 month outcome in Grade IV OA.
Controlled trials are needed to confirm these pilot data.
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