Prospective Assessment of the Efficacy of Hyaluronate Knee Injections in Patients With Osteoarthritis
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.
This study looks at the effect of an injectable medication called Hyalgan on the cartilage of the knee in people who have osteoarthritis ("wear and tear arthritis") of the knee. Hyalgan is a medication which is injected into the knee, and is FDA approved to treat knee arthritis. We will be using magnetic resonance imaging (MRI) and x-rays to look at knee cartilage to see how it responds over the course of a year to the injections. A comparison to patients taking oral pain medication will be made.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
45 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
seeking medical care for painful knee osteoarthritis
alignment based on AP standing radiographs of neutral to 10º of valgus
no prior surgery on the ipsilateral knee
no history of major trauma to either knee or either hip
no history of congenital hip dysplasia
No history of inflammatory synovitis or crystalline arthropathy
No history of systemic rheumatic disease
cruciate and collateral ligament stability, defined by clinical examination
meniscus intact (MRI grade II degenerative signal acceptable)
Noyes compartment score: no greater than 50% of cartilage thickness over an area greater than 15mm
If bilateral OA, the most painful knee, (as documented by VAS scale for pain) which qualifies for the study will be entered.
If taking glucosamine chondroitin sulfate, discontinue at least one month prior to HA injections
previous IA HA injection in the ipsilateral knee
IA steroid in the ipsilateral knee in the past 3 months
MR evidence of inflammatory or hypertrophic synovitis
Large joint effusion with a ballotable patella on baseline clinical exam
Inability to safely perform MR imaging
Active systemic infection
Active malignancy (except non-melanomatous skin cancer)
Allergies to HA or chicken products
Clinical symptoms of an acute meniscal tear (locking, new acute mechanical symptoms etc…)
A recent injury to the knee
Radiographic evidence of Grade III or IV Kellgren and Lawrence OA
Chondrocalcinosis on radiographs
Unwilling to discontinue or avoid glucosamine chondroitin sulfate for the 12 month study period
People taking blood thinners or who have bleeding problems
Anticipated lower extremity surgery during the next 12 months