Prospective Assessment of the Efficacy of Hyaluronate Knee Injections in Patients With Osteoarthritis

Sponsor

Hospital for Special Surgery, New York (Other)

Overall Status

Terminated

CT.gov ID

NCT00323778

Collaborator

Sanofi (Industry)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Hyalgan	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Prospective Assessment of the Efficacy of Intra-Articular Hyaluronate to Affect Extracellular Matrix Changes in Patients With Osteoarthritis

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age 45-90
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

Exclusion Criteria:

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
BMI >30 kg/m2