Optimization of Synvisc-One for Knee OA
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Investigating the Efficacy of Synvisc-One® (Hylan G-F 20) as Adjunctive Therapy for Patients With Knee Osteoarthritis (OA) Requiring Physical Therapy|
- Difference in pain score between groups [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]The primary objective of this study is the inter-group difference in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain subscale score over 12 and 24 weeks in subjects diagnosed with primary knee OA that are treated with standardized PT and Synvisc-One versus those that are treated with standardized PT and a sham injection.
- Difference in functional improvement between groups [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]To determine inter-group difference over 12 and 24 weeks in functional improvement using Chair Stands Timed Test
- Difference in isometric quadriceps strength between groups [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]To determine inter-group difference over 12 and 24 weeks in isometric quadricep strength
- Difference in isometric hamstrings strength between groups [ Time Frame: 12 to 24 weeks ] [ Designated as safety issue: No ]To determine inter-group difference over 12 and 24 weeks in hamstring strength
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Sham Comparator: Sham injection
Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.
|Other: Sham Injection|
Active Comparator: Synvisc-One Injection
Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.
|Device: Synvisc-One Injection|
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.
|Contact: Lori Strozniakfirstname.lastname@example.org|
|United States, Florida|
|Cleveland Clinic, Florida||Recruiting|
|Weston, Florida, United States, 33331|
|Contact: John Donohue, MD|
|Principal Investigator: John Donohue, MD|
|Principal Investigator:||Elaine Husni, MD MPH||The Cleveland Clinic|