Potential Risks and Mitigation Strategies During the Conduct of a Clinical Trial: An Industry Perspective.

Background: Every phase of a clinical trial should be designed in compliance with good clinical practices by following all relevant regulatory guidelines. Patient safety, data integrity and ethics are an integral part of a successful clinical trial which must be considered. Therefore, risk monitoring is an essential tool to identify the risks associated with conduct of any trial.

Arthroscopic debridement of the osteoarthritic knee combined with hyaluronic acid (Orthovisc) treatment: a case series and review of the literature.

Objective: An evaluation of safety and efficacy of high molecular weight hyaluronan (HA) delivered at the time of arthroscopic debridement of the osteoarthritic knee.

Methods: Thirty consecutive patients who met inclusion and exclusion criteria underwent arthroscopic debridement by a single surgeon and concomitant delivery of 6 ml/90 mg HA (Orthovisc). These patients were evaluated preoperatively, at 6 weeks, 3 and 6 months post-operatively.