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

February 4, 2008 updated by: Hospital for Special Surgery, New York

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

Sanofi

Investigators

  • Principal Investigator: Lisa A Mandl, MD MPH, Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Estimate)

February 6, 2008

Last Update Submitted That Met QC Criteria

February 4, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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