Osteoarthritis, KneeNCT00312533
Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee
An observational study of Osteoarthritis, Knee, run by Steadman Hawkins Research Foundation at 1 site in United States.
Trial summary
The goal of viscosupplementation is to replenish synovial fluid, which will improve patient symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has been shown to improve symptoms in patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Hylan F- 20
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Feb 2008
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 to 80 years
- with a diagnosis of osteoarthritis of the knee. Diagnosis will be based on radiographic examination (Kellgren-Lawrence 2 or 3) or by previous arthroscopic diagnosis.
- Surgical treatment for osteoarthritis will be limited to arthroscopic surgeries that include removal of loose bodies, resection of unstable meniscus tears and loose or unstable chondral flaps, removal of osteophytes if they limit extension, and lysis of adhesions. These types of treatments may provide symptomatic relief by increasing joint volume in knees with osteoarthritis and relieving joint contact pressures.
Who cannot join
- Patients with grade 4 Kellgren-Lawrence on radiographic examination will be excluded.
- Patients with a prior synovectomy on knee to be injected will be excluded.
- Patients will be excluded if they have rheumatoid disease or any other serious systemic disease, acute synovitis or excessive effusion, allergy to avian products/hyaluronan-based injection components/corticosteroid injection, pregnant, previous arthroscopic surgery within the last 6 months or had a joint infection within the previous 3 months.
- Patients who have undergone a prior synovectomy will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of viscosupplementation is to replenish synovial fluid, which will improve patient symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has been shown to improve symptoms in patients with osteoarthritis. Recent studies have shown that this improvement may be highly variable based on the time from treatment, especially in the first 12 weeks following treatment. The purpose of this study is to document the outcomes following a treatment protocol in which corticosteroid is used in addition to the initial Synvisc injection in the series of three injections.
Read the detailed description
Upon initial visit, all study patients will complete an informed consent. After consent, patients will complete the baseline questionnaire packet, which includes a questionnaire with several validated scoring systems. Following injection, patients will receive a diary to document any adverse events between the first and second injection. In one week, patients will return for a second visit to receive the second injection. Again they will be asked to maintain their diary of adverse events following the second injection. The patient will then receive the final injection at week 3 and will again complete a diary of events for one week. At 1 week, 3 weeks, 6 weeks, 12 weeks, and 26 weeks following the completed series of injections, the patients will complete a form that will include the pain, stiffness, and physical function subscales of the WOMAC score and a 10 point patient satisfaction question.
At 6 months, the patients will receive by mail the same questionnaire packet they received at baseline, with the addition of patient satisfaction and subsequent injury/treatment questions.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Hylan F- 20
- Keywords
- knee, injection, function, osteoarthritis
- 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.
Hylan F- 20Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steadman Hawkins Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Investigators
- John R Steadman, MD, Principal investigator, Steadman Hawkins Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312533
- Sponsor's protocol ID
- SHRF2006-01
- Status last verified
- Aug 2008
- First submitted
- 6 Apr 2006
- Last updated
- 25 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00312533
- Acronym / sponsor ID
- SHRF2006-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee, injection, function, osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Steadman Hawkins Research FoundationUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Apr 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 10 Apr 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.
The goal of viscosupplementation is to replenish synovial fluid, which will improve patient symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has been shown to improve symptoms in patients with osteoarthritis. Recent studies have shown that this improvement may be highly variable based on the time from treatment, especially in the first 12 weeks following treatment. The purpose of this study is to document the outcomes following a treatment protocol in which corticosteroid is used in addition to the initial Synvisc injection in the series of three injections.
Detailed description
Upon initial visit, all study patients will complete an informed consent. After consent, patients will complete the baseline questionnaire packet, which includes a questionnaire with several validated scoring systems. Following injection, patients will receive a diary to document any adverse events between the first and second injection. In one week, patients will return for a second visit to receive the second injection. Again they will be asked to maintain their diary of adverse events following the second injection. The patient will then receive the final injection at week 3 and will again complete a diary of events for one week. At 1 week, 3 weeks, 6 weeks, 12 weeks, and 26 weeks following the completed series of injections, the patients will complete a form that will include the pain, stiffness, and physical function subscales of the WOMAC score and a 10 point patient satisfaction question.
At 6 months, the patients will receive by mail the same questionnaire packet they received at baseline, with the addition of patient satisfaction and subsequent injury/treatment questions.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged 18 to 80 years
- with a diagnosis of osteoarthritis of the knee. Diagnosis will be based on radiographic examination (Kellgren-Lawrence 2 or 3) or by previous arthroscopic diagnosis.
- Surgical treatment for osteoarthritis will be limited to arthroscopic surgeries that include removal of loose bodies, resection of unstable meniscus tears and loose or unstable chondral flaps, removal of osteophytes if they limit extension, and lysis of adhesions. These types of treatments may provide symptomatic relief by increasing joint volume in knees with osteoarthritis and relieving joint contact pressures.
Key exclusion criteria (4 listed)
- Patients with grade 4 Kellgren-Lawrence on radiographic examination will be excluded.
- Patients with a prior synovectomy on knee to be injected will be excluded.
- Patients will be excluded if they have rheumatoid disease or any other serious systemic disease, acute synovitis or excessive effusion, allergy to avian products/hyaluronan-based injection components/corticosteroid injection, pregnant, previous arthroscopic surgery within the last 6 months or had a joint infection within the previous 3 months.
- Patients who have undergone a prior synovectomy will not be included.
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 |
|---|---|---|
| Hylan F- 20 | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Aug 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.
John R Steadman, MD principal investigator
Steadman Hawkins Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Steadman Hawkins Research Foundation 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 4 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 25 Aug 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.
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.
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 25 Aug 2008.