OsteoarthritisSYNVISC-ONENCT01625013
Synvisc-One for Younger, Active Patients With Osteoarthritis
A study testing Synvisc-One (G-F 20) in people with Osteoarthritis, run by Anthony Luke at 1 site in United States.
Trial summary
This study aims to study use of viscosupplementation as a treatment of pain for young individuals who are active. Typically viscosupplementation is considered an intervention for knee osteoarthritis often for older patients who are less active. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Synvisc-One (G-F 20)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 7 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female patients aged 30-50 years
- History of symptomatic unilateral primary or secondary knee OA for more than 6 months
- Signed written informed consent
- Radiographic evidence of Kellgren-Lawrence Grade I or II OA of the target knee
- Body Mass Index (BMI) < 30 kg/m2
- Activity criteria (Tegner score > 3)
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- Continued target knee OA pain despite conservative treatment ≥ 3 months (e.g., weight reduction, physical therapy, analgesics)
- Willing to withhold intake of NSAIDs (including COX-2 inhibitors) and analgesics, for a washout period of minimum 3 days up to 21 days prior to baseline visit (depending on medication)
- Willing to discontinue prohibited treatments and medications throughout study period
- Baseline inclusion criteria
- Completed OA medication washout period
- Target knee pain 4-8 (0-10 NRS) during most painful knee movement (Worst Knee Pain)
- If female, must have had a negative urine pregnancy test and used a medically acceptable form of contraception for at least 1 month prior to baseline and agree to continued use of contraception for the duration of the study. Otherwise, females must be surgically sterile, or postmenopausal (as documented in medical history) for at least 1 year. The fetal safety profile for G-F 20 is unknown. Pregnancy will affect the individual's regular activity levels. Females who become pregnant during the study will be excluded from the study. Subjects who become pregnant will be followed up by telephone every 3 months to check for any adverse effects. They will also be recommended to follow routine obstetric visits. Males should be able to father children as it has no expected effects on activity levels.
Who cannot join
- Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs, feathers, down, or poultry
- Clinically apparent tense effusion or other acute inflammation of the target knee at baseline
- History of target knee viscosupplementation treatment
- History of major surgery for OA in target knee including arthroplasty or tibial osteotomy
- Arthroscopic surgery or intraarticular steroid injection in target knee within six months of baseline visit
- Significant (as judged by the Investigator) alignment deformity of target knee
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- Ipsilateral symptomatic OA of hip or ankle; contralateral symptomatic OA of hip, knee, or ankle
- History of:
- Septic OA of any joint
- Inflammatory arthropathy such as RA, gout, pseudogout, lupus, crystalline inflammatory arthropathy
- Active infection of lower extremity
- Known significant acute and/or concurrent medical disease including, but not limited to current malignancy, history of transplant surgery, congestive heart failure, significant unstable cardiovascular disease, renal hepatic pulmonary, endocrine, metabolic, or GI condition
- Any known contraindication to acetaminophen
- Venous or lymphatic stasis in either leg
- Peripheral vascular disease
- Patient has been prescribed chronic opioid analgesics at time of baseline visit
- Concurrent multi-system or multi-limb trauma
- Patient plans to become pregnant during study period
- Patient plans to move significantly out of area, have surgery, or initiate or cease other OA treatments
- Knee pain improves during washout period
- Workman's Comp patient
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94158
About this study
Official title: Long-Term Management of "Younger, Active" Patients With Pain From Early Knee Osteoarthritis With Synvisc-One (Hylan G-F 20)
This study aims to study use of viscosupplementation as a treatment of pain for young individuals who are active. Typically viscosupplementation is considered an intervention for knee osteoarthritis often for older patients who are less active. Many young active patients can also develop knee osteoarthritis after trauma or surgery or for congenital reasons. Treatment of these patients commonly are steroid injections which have more biologically detrimental effects for cartilage compared to viscosupplementation Synvisc One injections which are a single injection will be used to determine effectiveness of reducing pain and maintaining an active healthy lifestyle for younger patients aged 30-50 years old.
Read the detailed description
This study will be an open label longitudinal cohort study with natural history over 3 years. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects enrolled in the cohort will have baseline functional testing performed including a motion gait analysis, 12 minute walk test, and 3-day accelerometer data. Subjects will receive a single 6 mL intra-articular injection of hylan G-F 20 in the target knee at baseline. All ongoing treatments will be monitored at 6 month intervals over the 3 year duration of the study. Patients can receive any other conservative treatments (e.g., oral medications, physical or other therapy, acupuncture, etc., except other injection treatments) and current treatments will be documented during each patient encounter. An initial injection of hylan G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20 gauge needle. A face to face follow up visit will be carried out 6 months after first injection with additional face to face meetings every 6 months thereafter unless the subject requires an additional injection of hylan G-F 20. Hylan G-F 20 treatments can be administered up to three times each year during the study duration. After each injection, follow up measures will be carried out using secure e-mail or phone contact at 6 weeks, 12 weeks, 18 weeks after each in-office evaluation or injection. Follow up will consist of WOMAC, Lysholm score, and Tegner score. Patients may return for retreatment of hylan G-F 20 if symptoms recur after at least 4 months following their previous injection and they meet the inclusion criteria with pain levels of WOMAC A1, C8, C9, C10 and/or C23 equaling 2 or more. Patients requiring three injections of hylan G-F 20 in 4 months or less will be allowed to exit the cohort after their six-month follow up following the third injection. Otherwise, patients will be followed until they reach the 3 year follow up, or drop out for other injection treatments or surgical treatment. Therefore, patients would potentially be able to receive up to 9 injections during the 3 year study.
- Conditions
- Osteoarthritis
- Being tested
- Synvisc-One (G-F 20)
- Keywords
- osteoarthritis, viscosupplementation, Active, Knee, Synvisc-One
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc-One (G-F 20)Device
Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Synvisc-One | Experimental | Not described Receives: Device: Synvisc-One (G-F 20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Worst Knee Pain" Likert Scale (0-10) Reported on Survey
Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain.
Patient Acceptable Symptom State (PASS) is a "Worst Knee Pain" reported score of less than 4 to be "positive". Patient Acceptable Symptom State (PASS) is the highest level of symptom beyond which patients consider themselves well.
Minimum Clinical Important Improvement (MCII) is improvement at any time in the 26 week time frame that "Worst Knee Pain" is reported at 2 points less than baseline.
Measured: 26 weeks after injection at baseline
Secondary outcomes (3)
Patient Acceptable Symptom Score (The Effect of Repeated Treatments)
Though symptoms can be improved for periods up to 6 months, pain symptoms can recur. The effect of repeated treatments of hylan G-F 20 will be studied with the Patient Acceptable Symptom Score less than 4/10 for the reported Worst Knee Pain score on follow up surveys.
Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain.
Patient Acceptable Symptom State (PASS) is a "Worst Knee Pain" reported score of less than 4 to be "positive". Patient Acceptable Symptom State (PASS) is the highest level of symptom beyond which patients consider themselves well.
Measured: 26 weeks post-injection Number 2, an average of 52 weeks
Minimal Clinical Important Improvement (The Effect of Repeated Injections)
Though symptoms can be improved for periods up to 6 months, pain symptoms can recur. The effect of repeated treatments of hylan G-F 20 will be studied with the Minimal Clinical Important Improvement less than 2 points from baseline on a 10-point likert scale for the reported Worst Knee Pain score on any follow up survey within 3 months. Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. Patients can reinject after 4 months.
Measured: up to 15 months (within 3 months from the second Synvisc One injection)
Identify the Effects of Treatment on Activity Levels
To identify the effects of treatment with hylan G-F 20 on activity levels (using objective activity measures utilizing accelerometer and Physical Activity Enjoyment Scale (PACES) and quality of life scores (WOMAC, SF-12) comparing baseline to treatment at 3 months.
Measured: 26 weeks post-injection at baseline through 3 years post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startNov 2011
- Primary completion2 Oct 2017
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthony Luke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anthony Luke, University of California, San Francisco
- Investigators
- Anthony Luke, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625013
- Sponsor's protocol ID
- UCSF-SYNVISC-ONE 001
- Acronym
- SYNVISC-ONE
- Status last verified
- Apr 2021
- First submitted
- 11 Jun 2012
- Last updated
- 7 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Management of "Younger, Active" Patients With Pain From Early Knee Osteoarthritis With Synvisc-One (Hylan G-F 20)
- ClinicalTrials.gov ID
- NCT01625013
- Acronym / sponsor ID
- SYNVISC-ONE / UCSF-SYNVISC-ONE 001
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, viscosupplementation, Active, Knee, Synvisc-One
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Anthony LukeUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Posted 27 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to study use of viscosupplementation as a treatment of pain for young individuals who are active. Typically viscosupplementation is considered an intervention for knee osteoarthritis often for older patients who are less active. Many young active patients can also develop knee osteoarthritis after trauma or surgery or for congenital reasons. Treatment of these patients commonly are steroid injections which have more biologically detrimental effects for cartilage compared to viscosupplementation Synvisc One injections which are a single injection will be used to determine effectiveness of reducing pain and maintaining an active healthy lifestyle for younger patients aged 30-50 years old.
Detailed description
This study will be an open label longitudinal cohort study with natural history over 3 years. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects enrolled in the cohort will have baseline functional testing performed including a motion gait analysis, 12 minute walk test, and 3-day accelerometer data. Subjects will receive a single 6 mL intra-articular injection of hylan G-F 20 in the target knee at baseline. All ongoing treatments will be monitored at 6 month intervals over the 3 year duration of the study. Patients can receive any other conservative treatments (e.g., oral medications, physical or other therapy, acupuncture, etc., except other injection treatments) and current treatments will be documented during each patient encounter. An initial injection of hylan G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20 gauge needle. A face to face follow up visit will be carried out 6 months after first injection with additional face to face meetings every 6 months thereafter unless the subject requires an additional injection of hylan G-F 20. Hylan G-F 20 treatments can be administered up to three times each year during the study duration. After each injection, follow up measures will be carried out using secure e-mail or phone contact at 6 weeks, 12 weeks, 18 weeks after each in-office evaluation or injection. Follow up will consist of WOMAC, Lysholm score, and Tegner score. Patients may return for retreatment of hylan G-F 20 if symptoms recur after at least 4 months following their previous injection and they meet the inclusion criteria with pain levels of WOMAC A1, C8, C9, C10 and/or C23 equaling 2 or more. Patients requiring three injections of hylan G-F 20 in 4 months or less will be allowed to exit the cohort after their six-month follow up following the third injection. Otherwise, patients will be followed until they reach the 3 year follow up, or drop out for other injection treatments or surgical treatment. Therefore, patients would potentially be able to receive up to 9 injections during the 3 year study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synvisc-One | Experimental | Device: Synvisc-One (G-F 20) |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male or female patients aged 30-50 years
- History of symptomatic unilateral primary or secondary knee OA for more than 6 months
- Signed written informed consent
- Radiographic evidence of Kellgren-Lawrence Grade I or II OA of the target knee
- Body Mass Index (BMI) < 30 kg/m2
Key exclusion criteria (21 listed)
- Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs, feathers, down, or poultry
- Clinically apparent tense effusion or other acute inflammation of the target knee at baseline
- History of target knee viscosupplementation treatment
- History of major surgery for OA in target knee including arthroplasty or tibial osteotomy
- Arthroscopic surgery or intraarticular steroid injection in target knee within six months of baseline visit
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 |
|---|---|---|
| Synvisc-One (G-F 20)Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years. | Device | Synvisc-One |
Primary outcome
"Worst Knee Pain" Likert Scale (0-10) Reported on Survey
Time frame: 26 weeks after injection at baseline
Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. Patient Acceptable Symptom State (PASS) is a "Worst Knee Pain" reported score of less than 4 to be "positive". Patient Acceptable Symptom State (PASS) is the highest level of symptom beyond which patients consider themselves well. Minimum Clinical Important Improvement (MCII) is improvement at any time in the 26 week time frame that "Worst Knee Pain" is reported at 2 points less than baseline.
3 secondary outcomes
Patient Acceptable Symptom Score (The Effect of Repeated Treatments)
Time frame: 26 weeks post-injection Number 2, an average of 52 weeks
Minimal Clinical Important Improvement (The Effect of Repeated Injections)
Time frame: up to 15 months (within 3 months from the second Synvisc One injection)
Identify the Effects of Treatment on Activity Levels
Time frame: 26 weeks post-injection at baseline through 3 years post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anthony Luke, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synvisc-One (G-F 20) in people with Osteoarthritis, run by Anthony Luke 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 21 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 7 May 2021. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
"Worst Knee Pain" Likert Scale (0-10) Reported on Survey (time frame: 26 weeks after injection at baseline). 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 7 May 2021.