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CompletedNCT01243814Updated Mar 20, 2012

A Double-blind RCT of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle

An interventional study of hyaluronate intra-articular injection and placebo injection in Osteoarthritis, sponsored by Henry DeGroot, M.D.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-20.

Sponsored by Henry DeGroot, M.D. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To compare the therapeutic effect of single intra-articular injection of hyaluronate with a single intra-articular injection of normal saline (placebo) for osteoarthritis of the ankle.

Read the detailed description

This study is a randomized, prospective, double-blind (blinded observer) , saline solution-controlled, parallel experimental design. The study device is SUPARTZ (Seikagaku Corporation, Tokyo, Japan) a brand of sodium hyaluronate.

02

Conditions studied

  • Osteoarthritis

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Keywords

  • hyaluronate
  • hyaluronic acid
  • viscosupplementation
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 69 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Henry DeGroot, M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • To be eligible, subjects had to be at least 18 years old, not pregnant, and have pain and osteoarthritis of the ankle of at least stage 2 on the Kellgren and Lawrence scale.
  • Their AOFAS score had to be 90 points or less out of a possible 100 points.
  • Eligible subjects had to be willing to discontinue all pain medications and NSAIDs other than the rescue pain medications provided in the study.

Exclusion criteria

Exclusion Criteria:

  • Persons with systemic inflammatory condition or infection of the ankle or nearby soft tissues,
  • an injection of steroid or surgery on the involved joint within 6 months,
  • local cellulitis, rash, skin condition
  • diabetic or neuropathic Charcot arthropathy,
  • significant vascular insufficiency,
  • current treatment with anticoagulants,
  • lower extremity pain syndromes, sciatica, sprains, plantar fasciitis,
  • significant ankle instability or malalignment,
  • any known allergy to any of the components of either injection, known or suspected allergy to birds or bird products,
  • disabling degenerative joint disease of the ipsilateral hip, knee or foot were ineligible for the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Active comparator
    supartz

    active intervention arm

    Device: hyaluronate intra-articular injection

  • Placebo comparator
    saline injection

    placebo intervention arm

    Device: placebo injection

Interventions

  • Devicehyaluronate intra-articular injection

    joint injection in ankle with hyaluronate

    Also known as: Supartz

  • Deviceplacebo injection

    joint injection with saline solution for placebo

    Also known as: saline injection

06

What researchers measure

Primary outcomes

  1. AOFAS score, difference from mean at 6 weeks and 12 weeks

    American Orthopaedic Foot and Ankle score

    Time frame: 6 weeks 12 weeks

07

Study locations

1 site
  • The office of Dr. Henry DeGroot
    Newton, Massachusetts 02462, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01243814
Lead sponsor
Henry DeGroot, M.D.
First posted
Nov 19, 2010
Start date
Oct 2009
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Mar 20, 2012

Study contacts

Henry DeGroot, MD
principal investigator · Newton-Wellesley Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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