Optimization of Synvisc-One for Knee OA
|ClinicalTrials.gov Identifier: NCT02029703|
Recruitment Status : Terminated (Enrollment Goals not met)
First Posted : January 8, 2014
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: Synvisc-One Injection Other: Sham Injection||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Investigating the Efficacy of Synvisc-One® (Hylan G-F 20) as Adjunctive Therapy for Patients With Knee Osteoarthritis (OA) Requiring Physical Therapy|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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|
- Difference in Pain Score Between Groups [ Time Frame: 12 and 24 weeks ]
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.
The scale range is 0-100 with a higher score being better. The pain scale is a subscale of the overall KOOS, and there are no smaller subscales described or used to create this score.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029703
|United States, Florida|
|Cleveland Clinic, Florida|
|Weston, Florida, United States, 33331|
|Principal Investigator:||Elaine Husni, MD MPH||The Cleveland Clinic|