Hydros and Hydros-TA have been evaluated in a multi-center, randomized, double blinded clinical trial. The study was designed to evaluate trends in the safety and performance of Hydros and Hydros-TA compared to Synvisc-One®, a commercially available, single injection viscosupplementation product. A total of 98 subjects were enrolled, treated, and followed for six months post-treatment.
- Hydros-TA showed trends toward improvement in pain reduction compared to Synvisc-One at all follow-up timepoints.
- Hydros-TA showed a trend towards a faster onset of pain relief compared to the non-steroid containing products evaluated in the study. Hydros-TA provided a 43.5mm mean reduction from baseline pain at the 2 week time point compared to a mean reduction of 37.7mm and 32.3mm for Synvisc-One and Hydros, respectively. The percentage of subjects who responded favorably to the product (as measured by the OMERACT-OARSI responder rate) was higher in the Hydros and Hydros-TA groups when compared to Synvisc-One.
- There were fewer adverse events which were judged to be likely related to Hydros-TA than to Synvisc-One.
* Synvisc-One® is a registered trademark of Genzyme Corporation.
Future Clinical Trials
Carbylan BioSurgery plans to conduct additional trials at sites in the US and internationally.