Pilot Study of Therapy With Hylan G-F 20 Exercise Capacity (CORT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01810848|
Recruitment Status : Terminated (Enrollment too low.)
First Posted : March 14, 2013
Last Update Posted : March 29, 2016
Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA. Initiation and maintenance of even low-levels of physical activity is critical for management of cardiac risk. Patients with osteoarthritis have been shown to have poorer aerobic conditioning, lower daily physical activity levels and lower self-efficacy for exercise than non-OA cohorts.
It has been established that there exists a consistent gradient across activity groups indicating greater longevity and reduced risk of CHD, CVD, and stroke, in more active individuals. Available research suggests the greatest gains in cardiovascular fitness occur in moving a sedentary individual to even low levels of physical activity, and 12 weeks is enough to demonstrate change in the risk profile of at-risk individuals.
Finally, appropriate levels of aerobic and strength training have been shown to be beneficial in treatment of osteoarthritis of the knee. This study will evaluate the effectiveness of hylan G-F 20 (single injection preparation) in promoting greater levels of physical activity and fitness as measured by MET level compared to an exercise-only cohort; evaluating both the change in physical function as well as the cardiovascular risk profile. This is a randomized, single-blinded clinical trial comparing injection of the knee joint with Hylan GF-20 to sham procedure. Subjects will undergo a regular exercise program for 6 months following randomization.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: Hylan G-F 20 Other: Control||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Pilot Study of the Impact of Viscosupplementation Therapy With Hylan G-F 20 (Single Injection) on Exercise Tolerance - Implications for Patients With Cardiovascular Risk|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: Hylan G-F 20
Patients will receive a single injection of hylan G-F 20 6ml into affected knee. Injections will be performed under fluoroscopic guidance.
Device: Hylan G-F 20
Synvisc is an elastoviscous high molecular weight fluid which is injected into the knee joint ("intra-articular") for relief of pain from osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
Sham Comparator: Control
Patients will receive a single sham puncture into the affected knee. Sham punctures will be identical to the treatment injections in all other respects, including duration, use of sterile drapes, sterile preparation, and dimming of the lights. This procedure will include a 22g needle stick through the skin without violating the joint capsule or performing arthrocentesis.
Control is puncture of the skin at the site of the knee.
- MET Level (Exercise capacity) [ Time Frame: 6 Months ]
- KOOS (Knee Injury and Osteoarthritis Outcome Score) [ Time Frame: 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810848
|United States, Ohio|
|McConnell Heart Health Center|
|Columbus, Ohio, United States, 43214|
|Principal Investigator:||Joseph J Ruane, DO||OhioHealth|