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

This study has been terminated.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00323778
First received: May 8, 2006
Last updated: February 4, 2008
Last verified: February 2008
History of Changes
  Purpose

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 Intervention Phase
Knee Osteoarthritis
 Drug: Hyalgan
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Prospective Assessment of the Efficacy of Intra-Articular Hyaluronate to Affect Extracellular Matrix Changes in Patients With Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Estimated Enrollment: 40
Study Start Date: May 2006
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323778

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Sanofi
Investigators
Principal Investigator: Lisa A Mandl, MD MPH Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Lisa A. Mandl MD MPH, Hospital for Special Surgery
ClinicalTrials.gov Identifier: NCT00323778     History of Changes
Other Study ID Numbers: 25107
Study First Received: May 8, 2006
Last Updated: February 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospital for Special Surgery, New York:
hyalgan
knee
osteoarthritis
MRI

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013