OsteoarthritisNCT01243814
A Double-blind RCT of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle
A study testing hyaluronate intra-articular injection in people with Osteoarthritis, run by Henry DeGroot, M.D. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- hyaluronate intra-articular injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The office of Dr. Henry DeGroot
Newton, Massachusetts, 02462
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study of the Relative Efficacy of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle
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.
- Conditions
- Osteoarthritis
- Being tested
- hyaluronate intra-articular injection, placebo injection
- Keywords
- hyaluronate, hyaluronic acid, viscosupplementation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronate intra-articular injectionDevice
Also called Supartz
joint injection in ankle with hyaluronate
placebo injectionDevice
Also called saline injection
joint injection with saline solution for placebo
| Study group | Role | What they receive |
|---|---|---|
| supartz | Active comparator | active intervention arm Receives: Device: hyaluronate intra-articular injection |
| saline injection | Placebo comparator | placebo intervention arm Receives: Device: placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS score, difference from mean at 6 weeks and 12 weeks
American Orthopaedic Foot and Ankle score
Measured: 6 weeks 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry DeGroot, M.D.
- Sponsor type
- University, hospital or other
- Investigators
- Henry DeGroot, MD, Principal investigator, Newton-Wellesley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243814
- Sponsor's protocol ID
- N08-429
- Status last verified
- Nov 2010
- First submitted
- 18 Nov 2010
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study of the Relative Efficacy of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle
- ClinicalTrials.gov ID
- NCT01243814
- Acronym / sponsor ID
- N08-429
- Conditions
- Osteoarthritis
- Keywords
- hyaluronate, hyaluronic acid, viscosupplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Henry DeGroot, M.D.University, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supartz | Active comparator | Device: hyaluronate intra-articular injectionactive intervention arm |
| saline injection | Placebo comparator | Device: placebo injectionplacebo intervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronate intra-articular injectionAlso: Supartzjoint injection in ankle with hyaluronate | Device | supartz |
| placebo injectionAlso: saline injectionjoint injection with saline solution for placebo | Device | saline injection |
Primary outcome
AOFAS score, difference from mean at 6 weeks and 12 weeks
Time frame: 6 weeks 12 weeks
American Orthopaedic Foot and Ankle score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry DeGroot, MD principal investigator
Newton-Wellesley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyaluronate intra-articular injection in people with Osteoarthritis, run by Henry DeGroot, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS score, difference from mean at 6 weeks and 12 weeks (time frame: 6 weeks 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.