Pilot Study of Therapy With Hylan G-F 20 Exercise Capacity
| Status: | Terminated |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | June 2015 |
Pilot Study of the Impact of Viscosupplementation Therapy With Hylan G-F 20 (Single Injection) on Exercise Tolerance - Implications for Patients With Cardiovascular Risk
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.
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.
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)
- Established CAD per clinical or imaging diagnosis
- Allowed medications include stable prescription dose of NSAIDS and/or tramadol. Ad
lib use of OTC analgesics will be allowed in both groups.
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).
- Prosthetic implant in hip and/or lower extremities.
- Any clinical indication for arthroscopic surgery at the time of enrollment.
- Planned surgeries during the trial period (e.g., scheduled/awaiting for arthroscopy
or a knee replacement procedure for OA of the knee).
- Plans to initiate other OA treatments including, but not limited to
non-pharmacologic, pharmacologic, surgical, chiropractic, acupuncture, yoga, Tai chi,
physical therapy during the study period
- Any other intra-articular knee joint injection during the study.
- History of systemic and/or intra-articular steroid injection in target knee within
six months of baseline visit.
- History of arthroscopic surgery in affected knee in past 12 months at baseline visit.
- Cruciate/collateral knee ligament instability, ligament laxity, or meniscal
instability of target knee.
- Significant alignment deformity such as varus/valgus of target knee in the judgment
of the investigator.
- Venous or lymphatic stasis in either leg.
- Peripheral vascular disease.
- Concurrent multi-system or multi-limb trauma.
- Pregnancy or mothers who are breastfeeding. Urine pregnancy test will be administered
at baseline for women of childbearing potential.
- On chronic opioid analgesic therapy that cannot be altered. Chronic is defined as ≥6
months.
- Known contraindication to acetaminophen.
- Currently enrolled in another clinical trial or history of trial enrollment within
three months at baseline.
- Plans to move/relocate significantly out of area during study period.
- Workman's Compensation beneficiary at base line visit.
- The presence of secondary diagnosis such as neuropathy (any type), radiculopathy, or
other nervous system conditions in the judgment of the investigator, contributing to
other lower extremity pain that limits activity.
- Physical Therapy for OA of the lower extremity within 6 months prior to enrollment
into the study.
- Any musculoskeletal condition besides OA of the knee that limits exercise or normal
daily function.
- Acute coronary conditions that are deemed inappropriate for participating in an
exercise program.
- Pulmonary conditions limiting functional capacity.
- Known allergy to hylan G-F 20 or any, of its components, or to avian proteins, eggs,
feathers, down or poultry.
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