NCT02029703

Optimization of Synvisc-One for Knee OA

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Elaine Husni · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Synvisc-One Injection
OTHER	Sham Injection

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-01-08
• Last updated: 2017-04-21
• Results posted: 2017-04-21

Locations

1 site across 1 country: United States