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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.
Enrollment
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Volunteers
Inclusion criteria
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:
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.
Primary purpose
Allocation
Interventional model
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9 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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