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TerminatedNCT00323778Updated Feb 6, 2008

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

A Phase 3 interventional study of Hyalgan in Knee Osteoarthritis, sponsored by Hospital for Special Surgery, New York. Terminated at 1 site in United States. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2008-02-06.

Sponsored by Hospital for Special Surgery, New York · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
45 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • hyalgan
  • knee
  • osteoarthritis
  • MRI
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's planned enrollment of 40 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.

Browse Hospital for Special Surgery, New York studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Interventions

06

Study locations

1 site
  • Hospital for Special Surgery
    New York, New York 10021, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2006 and a primary completion of Sep 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2006
First posted
May 10, 2006
Start
May 2006
Primary completionActual
Sep 2007
Last update
Feb 6, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00323778
Lead sponsor
Hospital for Special Surgery, New York
Collaborators
Sanofi
First posted
May 10, 2006
Start date
May 2006
Primary completion
Sep 2007
Last update
Feb 6, 2008

Study contacts

Lisa A Mandl, MD MPH
principal investigator · Hospital for Special Surgery, New York
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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