Knee OsteoarthritisPhase 3NCT00323778
Prospective Assessment of the Efficacy of Hyaluronate Knee Injections in Patients With Osteoarthritis
A Phase 3 study testing Hyalgan in people with Knee Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hyalgan
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Sep 2007
- Phase
- Phase 3
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hyalgan
- Keywords
- hyalgan, knee, osteoarthritis, MRI
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyalganDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
- Study startMay 2006
- Primary completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- 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 3
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Lisa A Mandl, MD MPH, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323778
- Sponsor's protocol ID
- 25107
- Status last verified
- Feb 2008
- First submitted
- 8 May 2006
- Last updated
- 6 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of the Efficacy of Intra-Articular Hyaluronate to Affect Extracellular Matrix Changes in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT00323778
- Acronym / sponsor ID
- 25107
- Conditions
- Knee Osteoarthritis
- Keywords
- hyalgan, knee, osteoarthritis, MRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- May 2006
- Primary completion
- Sep 2007 (actual)
- First posted
- 10 May 2006 (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.
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Hyalgan | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2008.
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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.
Lisa A Mandl, MD MPH principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyalgan in people with Knee Osteoarthritis, run by Hospital for Special Surgery, New York 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 13 inclusion and 16 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: stopped early, as of the sponsor's last update on 6 Feb 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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.
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 6 Feb 2008.