Optimization of Synvisc-One for Knee OA

Knee Osteoarthritis Clinical Trial

Official title: Investigating the Efficacy of Synvisc-One® (Hylan G-F 20) as Adjunctive Therapy for Patients With Knee Osteoarthritis (OA) Requiring Physical Therapy

Status Recruiting

Clinical Trial Summary

The study hypothesis is that the use of Synvisc-One will improve physical therapy compliance and performance, resulting in improved knee function and pain when compared to a group that receives a sham injection (an injection that does not have medicine) only before a standardized physical therapy regimen over 10 weeks.

Clinical Trial Description

This is a prospective, randomized, double-blind (subject and physical therapist), sham needle injection controlled, single center, multi-site study.

Subjects with primary osteoarthritis knee pain will be randomly assigned to a 6 ml intra-articular injection of Synvisc-One or sham needle injection.

The post-treatment course of physical therapy will begin between Day 3 and Day 14 and will last up to 12 weeks in duration (PT ends at study Week 12). Subjects are encouraged to complete between 6 and 16 physical therapy visits within 10-12 weeks of physical therapy treatment as determined by the treating Physical Therapist. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT02029703
• Study type: Interventional
• Source: The Cleveland Clinic
• Contact: Lori Strozniak
• Phone: 216-444-7722
• Email: stroznil@ccf.org
• Status: Recruiting
• Phase: N/A
• Start date: August 2012