Knee OsteoarthritisPhase 1CORTNCT01810848
Pilot Study of Therapy With Hylan G-F 20 Exercise Capacity
A Phase 1 study testing Hylan G-F 20 in people with Knee Osteoarthritis, run by OhioHealth at 1 site in United States.
Trial summary
Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hylan G-F 20
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2015
- Phase
- Phase 1
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female individuals aged between 40 and 70 meeting the American College of Rheumatology (ACR) criteria for primary knee OA with radiographic and symptomatic evidence of TF OA for ≥6 months.
- Radiographic osteoarthritis Kellgren-Lawrence Grade II-III (radiographs taken at entry) in affected knee.
- Average pain numeric rating (defined as moderate level) of 4 - 8 on a scale of zero to 10 over the past week.
- No previous viscosupplement therapy in any joint in past 12 months at the time of randomization.
- No intra-articular steroids in the past 6 months.
- Currently sedentary per American College of Sports Medicine (ACSM) criteria (MET level <9) and at least one of the following cardiovascular risk factors:
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- Obesity (BMI between 30 and 40)
- Diabetes mellitus
- HTN (JNC guidelines for HTN stage 1: Systolic >/=140 and diastolic >/= 90)
- Dyslipidemia (ATP3 Guidelines for dyslipidemia: LDL>160, total cholesterol >/=240 and HDL<40)
- Established CAD per clinical or imaging diagnosis
- Allowed medications include stable prescription dose of NSAIDS and/or tramadol. Ad lib use of OTC analgesics will be allowed in both groups.
Who cannot join
- Grade I and IV OA.
- History of viscosupplementation in any joint in the past 12 months at the time of baseline visit.
- Isolated patello-femoral OA or isolated anterior knee pain (patello-femoral OA co-existing with tibia femoral KOA may be included).
- Symptomatic bilateral knee OA (unless the contra-lateral knee involvement is limited to radiographic OA and not symptomatic).
- Ipsi-lateral symptomatic OA of hip or ankle; contra-lateral symptomatic OA of hip, knee, or ankle, or clinical evidence of hip disease.
- Clinically apparent tense effusion or other acute inflammation of the target knee at baseline.
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- History of:
- Septic OA of any joint
- Inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus, crystalline arthropathy, chondrocalcinosis and other rheumatology diagnosis in judgment of the investigator.
- Active infection of lower extremity (e.g., cellulitis).
- Prosthetic implant in hip and/or lower extremities.
- Any clinical indication for arthroscopic surgery at the time of enrollment.
- Planned surgeries during the trial period (e.g., scheduled/awaiting for arthroscopy or a knee replacement procedure for OA of the knee).
- Plans to initiate other OA treatments including, but not limited to non-pharmacologic, pharmacologic, surgical, chiropractic, acupuncture, yoga, Tai chi, physical therapy during the study period
- Any other intra-articular knee joint injection during the study.
- History of systemic and/or intra-articular steroid injection in target knee within six months of baseline visit.
- History of arthroscopic surgery in affected knee in past 12 months at baseline visit.
- Cruciate/collateral knee ligament instability, ligament laxity, or meniscal instability of target knee.
- Significant alignment deformity such as varus/valgus of target knee in the judgment of the investigator.
- Venous or lymphatic stasis in either leg.
- Peripheral vascular disease.
- Concurrent multi-system or multi-limb trauma.
- Pregnancy or mothers who are breastfeeding. Urine pregnancy test will be administered at baseline for women of childbearing potential.
- On chronic opioid analgesic therapy that cannot be altered. Chronic is defined as ≥6 months.
- Known contraindication to acetaminophen.
- Currently enrolled in another clinical trial or history of trial enrollment within three months at baseline.
- Plans to move/relocate significantly out of area during study period.
- Workman's Compensation beneficiary at base line visit.
- The presence of secondary diagnosis such as neuropathy (any type), radiculopathy, or other nervous system conditions in the judgment of the investigator, contributing to other lower extremity pain that limits activity.
- Physical Therapy for OA of the lower extremity within 6 months prior to enrollment into the study.
- Any musculoskeletal condition besides OA of the knee that limits exercise or normal daily function.
- Acute coronary conditions that are deemed inappropriate for participating in an exercise program.
- Pulmonary conditions limiting functional capacity.
- Known allergy to hylan G-F 20 or any, of its components, or to avian proteins, eggs, feathers, down or poultry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Impact of Viscosupplementation Therapy With Hylan G-F 20 (Single Injection) on Exercise Tolerance - Implications for Patients With Cardiovascular Risk
Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA. Initiation and maintenance of even low-levels of physical activity is critical for management of cardiac risk. Patients with osteoarthritis have been shown to have poorer aerobic conditioning, lower daily physical activity levels and lower self-efficacy for exercise than non-OA cohorts.
It has been established that there exists a consistent gradient across activity groups indicating greater longevity and reduced risk of CHD, CVD, and stroke, in more active individuals. Available research suggests the greatest gains in cardiovascular fitness occur in moving a sedentary individual to even low levels of physical activity, and 12 weeks is enough to demonstrate change in the risk profile of at-risk individuals.
Finally, appropriate levels of aerobic and strength training have been shown to be beneficial in treatment of osteoarthritis of the knee. This study will evaluate the effectiveness of hylan G-F 20 (single injection preparation) in promoting greater levels of physical activity and fitness as measured by MET level compared to an exercise-only cohort; evaluating both the change in physical function as well as the cardiovascular risk profile. This is a randomized, single-blinded clinical trial comparing injection of the knee joint with Hylan GF-20 to sham procedure. Subjects will undergo a regular exercise program for 6 months following randomization.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hylan G-F 20, Control
- Keywords
- Knee Osteoarthritis, Osteoarthritis, Synvisc, Hylan G-F 20, Exercise, Cardiovascular risk, Knee pain, Pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylan G-F 20Device
Also called Synvisc, Sodium hyaluronate
Synvisc is an elastoviscous high molecular weight fluid which is injected into the knee joint ("intra-articular") for relief of pain from osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
ControlOther
Control is puncture of the skin at the site of the knee.
| Study group | Role | What they receive |
|---|---|---|
| Hylan G-F 20 | Active comparator | Patients will receive a single injection of hylan G-F 20 6ml into affected knee. Injections will be performed under fluoroscopic guidance. Receives: Device: Hylan G-F 20 |
| Control | Sham comparator | Patients will receive a single sham puncture into the affected knee. Sham punctures will be identical to the treatment injections in all other respects, including duration, use of sterile drapes, sterile preparation, and dimming of the lights. This procedure will include a 22g needle stick through the skin without violating the joint capsule or performing arthrocentesis. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
MET Level (Exercise capacity)
Measured: 6 Months
Secondary outcomes (1)
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Enrollment too low.
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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Joseph J Ruane, DO, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810848
- Sponsor's protocol ID
- CORT
- Acronym
- CORT
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2013
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Impact of Viscosupplementation Therapy With Hylan G-F 20 (Single Injection) on Exercise Tolerance - Implications for Patients With Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT01810848
- Acronym / sponsor ID
- CORT / CORT
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Osteoarthritis, Synvisc, Hylan G-F 20, Exercise, Cardiovascular risk, Knee pain, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment too low.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Mar 2013 (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.
Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA. Initiation and maintenance of even low-levels of physical activity is critical for management of cardiac risk. Patients with osteoarthritis have been shown to have poorer aerobic conditioning, lower daily physical activity levels and lower self-efficacy for exercise than non-OA cohorts.
It has been established that there exists a consistent gradient across activity groups indicating greater longevity and reduced risk of CHD, CVD, and stroke, in more active individuals. Available research suggests the greatest gains in cardiovascular fitness occur in moving a sedentary individual to even low levels of physical activity, and 12 weeks is enough to demonstrate change in the risk profile of at-risk individuals.
Finally, appropriate levels of aerobic and strength training have been shown to be beneficial in treatment of osteoarthritis of the knee. This study will evaluate the effectiveness of hylan G-F 20 (single injection preparation) in promoting greater levels of physical activity and fitness as measured by MET level compared to an exercise-only cohort; evaluating both the change in physical function as well as the cardiovascular risk profile. This is a randomized, single-blinded clinical trial comparing injection of the knee joint with Hylan GF-20 to sham procedure. Subjects will undergo a regular exercise program for 6 months following randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hylan G-F 20 | Active comparator | Device: Hylan G-F 20Patients will receive a single injection of hylan G-F 20 6ml into affected knee. Injections will be performed under fluoroscopic guidance. |
| Control | Sham comparator | Other: ControlPatients will receive a single sham puncture into the affected knee. Sham punctures will be identical to the treatment injections in all other respects, including duration, use of sterile drapes, sterile preparation, and dimming of the lights. This procedure will include a 22g needle stick through the skin without violating the joint capsule or performing arthrocentesis. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female individuals aged between 40 and 70 meeting the American College of Rheumatology (ACR) criteria for primary knee OA with radiographic and symptomatic evidence of TF OA for ≥6 months.
- Radiographic osteoarthritis Kellgren-Lawrence Grade II-III (radiographs taken at entry) in affected knee.
- Average pain numeric rating (defined as moderate level) of 4 - 8 on a scale of zero to 10 over the past week.
- No previous viscosupplement therapy in any joint in past 12 months at the time of randomization.
- No intra-articular steroids in the past 6 months.
Key exclusion criteria (34 listed)
- Grade I and IV OA.
- History of viscosupplementation in any joint in the past 12 months at the time of baseline visit.
- Isolated patello-femoral OA or isolated anterior knee pain (patello-femoral OA co-existing with tibia femoral KOA may be included).
- Symptomatic bilateral knee OA (unless the contra-lateral knee involvement is limited to radiographic OA and not symptomatic).
- Ipsi-lateral symptomatic OA of hip or ankle; contra-lateral symptomatic OA of hip, knee, or ankle, or clinical evidence of hip disease.
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 G-F 20Also: Synvisc, Sodium hyaluronateSynvisc is an elastoviscous high molecular weight fluid which is injected into the knee joint ("intra-articular") for relief of pain from osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. | Device | Hylan G-F 20 |
| ControlControl is puncture of the skin at the site of the knee. | Other | Control |
Primary outcome
MET Level (Exercise capacity)
Time frame: 6 Months
1 secondary outcome
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: 6 Months
Results and safety
The study was stopped early (reason given: Enrollment too low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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.
Joseph J Ruane, DO principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hylan G-F 20 in people with Knee Osteoarthritis, run by OhioHealth 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 12 inclusion and 34 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 29 Mar 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (reason given: Enrollment too low.). 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.
What does the primary outcome measure?
MET Level (Exercise capacity) (time frame: 6 Months). 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 29 Mar 2016.