Pilot Study of the Impact of Viscosupplementation Therapy With Hylan G-F 20 (Single Injection) on Exercise Tolerance - Implications for Patients With Cardiovascular Risk
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- OhioHealth
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- MET Level (Exercise capacity)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female individuals aged between 40 and 70 meeting the American College of Rheumatology (ACR) criteria for primary knee OA with radiographic and symptomatic evidence of TF OA for ≥6 months.
- •Radiographic osteoarthritis Kellgren-Lawrence Grade II-III (radiographs taken at entry) in affected knee.
- •Average pain numeric rating (defined as moderate level) of 4 - 8 on a scale of zero to 10 over the past week.
- •No previous viscosupplement therapy in any joint in past 12 months at the time of randomization.
- •No intra-articular steroids in the past 6 months.
- •Currently sedentary per American College of Sports Medicine (ACSM) criteria (MET level \<9) and at least one of the following cardiovascular risk factors:
- •Obesity (BMI between 30 and 40)
- •Diabetes mellitus
- •HTN (JNC guidelines for HTN stage 1: Systolic \>/=140 and diastolic \>/= 90)
- •Dyslipidemia (ATP3 Guidelines for dyslipidemia: LDL\>160, total cholesterol \>/=240 and HDL\<40)
Exclusion Criteria
- •Grade I and IV OA.
- •History of viscosupplementation in any joint in the past 12 months at the time of baseline visit.
- •Isolated patello-femoral OA or isolated anterior knee pain (patello-femoral OA co-existing with tibia femoral KOA may be included).
- •Symptomatic bilateral knee OA (unless the contra-lateral knee involvement is limited to radiographic OA and not symptomatic).
- •Ipsi-lateral symptomatic OA of hip or ankle; contra-lateral symptomatic OA of hip, knee, or ankle, or clinical evidence of hip disease.
- •Clinically apparent tense effusion or other acute inflammation of the target knee at baseline.
- •History of:
- •Septic OA of any joint
- •Inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus, crystalline arthropathy, chondrocalcinosis and other rheumatology diagnosis in judgment of the investigator.
- •Active infection of lower extremity (e.g., cellulitis).
Outcomes
Primary Outcomes
MET Level (Exercise capacity)
Time Frame: 6 Months
Secondary Outcomes
- KOOS (Knee Injury and Osteoarthritis Outcome Score)(6 Months)