Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip Replacement

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty

Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement

The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip arthroplasty

Key Inclusion Criteria:

• Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, III
• Planning to undergo unilateral THA
• In good health and capable of undergoing THA with spinal block and sedation anesthesia
• No additional planned surgeries during the course of the trial
• Willing and able to complete the study procedures and pain scales and to communicate meaningfully in English

Key Exclusion Criteria:

• A body mass index greater than 40
• Known bleeding disorder or is taking agents affecting coagulation preoperatively
• A medical condition that could adversely impact the patient's participation, safety, or conduct of the study
• Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes
• Previous hip arthroplasty of the same hip
• Participated in another clinical trial within 30 days of the planned hip surgery