Knee OsteoarthritisNCT02029703
Optimization of Synvisc-One for Knee OA
A study testing Synvisc-One Injection in people with Knee Osteoarthritis, run by Elaine Husni at 1 site in United States.
Trial summary
The study hypothesis is that the use of Synvisc-One will improve physical therapy compliance and performance, resulting in improved knee function and pain when compared to a group that receives a sham injection (an injection that does not have medicine) only before a standardized physical therapy regimen over 10 weeks. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Synvisc-One Injection
- 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
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects meeting the American College of Rheumatology (ACR) criteria for primary knee OA who are age 21 or greater with radiographic and symptomatic evidence of tibio-femoral OA for more than 6 months (unilateral, single joint, Kellgren-Lawrence Grading Scale Score of 2 or 3, medial or lateral +/- patellofemoral).
- Subjects with persistent target knee OA pain despite treatment ≥ 3 months with acetaminophen 4 grams or less or other OA pain treatments.
- Subjects willing to discontinue all prohibited treatments and medications (e.g. opioids, narcotic analgesics, Tramadol) throughout the study period.
- Subjects currently on prescription strength NSAIDs (Non steroidal antiinflammatory drugs) must maintain a stable regimen (no dose increase and no new analgesics) during the entire study period.
- Female subjects of child bearing potential must have a negative serum or urine pregnancy test prior to Synvisc-One® or sham injection.
- Female subjects of child bearing potential must agree to use a medically acceptable form of contraception for at least 1 month prior to Synvisc-One® or sham injection and must agree to continue the use of an acceptable form 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.
- Subjects willing and able to commit to a standard 10 week course of physical therapy.
- Subjects willing and able to sign written informed consent.
Who cannot join
- Kellgren-Lawrence Grading Scale score of Grade 1 or Grade 4 given the low efficacy of viscosupplements in this population and the KOOS is not validated in this patient population.
- Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs, feathers, down, or poultry.
- History of viscosupplementation in the target knee joint within 3 months of the baseline visit.
- Isolated patellofemoral OA or isolated anterior knee pain (patellofemoral OA coexisting with tibiofemoral knee OA may be included).
- Symptomatic bilateral knee OA (unless the contralateral knee involvement is limited to radiographic OA and not symptomatic).
- Ipsilateral symptomatic OA of hip or ankle; contralateral symptomatic OA of hip, knee, or ankle, or clinical evidence of hip disease.
Show all 36Show fewer
- Clinically apparent knee joint infection, tense effusion or other acute inflammation of the target knee at baseline.
- History of septic OA of any joint; and / or Inflammatory arthropathy such as RA (Rheumatoid Arthritis), gout, pseudogout, lupus, crystalline inflammatory arthropathy, chondrocalcinosis etc.
- Active infection of a lower extremity (e.g. cellulitis).
- Prosthetic implant in either knee.
- Subjects with any clinical indication for arthroscopic surgery.
- Subjects with a planned or scheduled surgery during the course of the study (scheduled or awaiting for arthroscopy or a knee replacement procedure for OA of the knee).
- Subjects with plans to initiate or cease other OA treatments including, but not limited to non- pharmacologic, pharmacologic, surgical, chiropractic, or acupuncture during the course of the study.
- Subjects with plans to initiate, cease or continue any other intra-articular knee joint injection during the course of the study.
- History of systemic and/or intra-articular steroid injection in target knee within one month prior to the baseline visit.
- History of open knee surgery in affected knee or history of arthroscopic surgery in affected knee in past year.
- History of complete menisectomy.
- Suspected meniscus injury, including a positive McMuray's test or significant joint line tenderness.
- Cruciate / collateral knee ligament instability, ligament laxity, or meniscal instability of target knee.
- Obvious cartilage defects producing mechanical symptoms (i.e. locking).
- Patellar tendonitis.
- Significant alignment deformity such as varus / valgus of target knee in the judgment of the investigator.
- Venous or lymphatic stasis in either leg.
- Past or current history of peripheral vascular disease pertaining to the involved limb.
- Concurrent multisystem or multilimb trauma.
- Known significant acute and / or concurrent medical comorbidities including, but not limited to current malignancy, history of transplant surgery, congestive heart failure, significant unstable cardiovascular disease, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, or neurological condition that in the judgment of the investigator would significantly impact life expectancy and / or the conduct of the trial.
- Known psychiatric disorder.
- Body mass index (BMI) > 40.
- Female subjects interested in conceiving a child during the study period.
- Currently pregnant or new mothers who are breastfeeding.
- Subjects currently prescribed chronic opioid analgesics at time of baseline visit that cannot be discontinued.
- Use of prohibited pain medications.
- Any known contraindication to acetaminophen.
- Subjects currently enrolled in any other experimental clinical trial or history of trial enrollment within three months of baseline.
- Subjects who plan to move or relocate out of area inhibiting their ability to complete the entire physical therapy regimen as defined by the protocol and prescribed by the investigator.
- Knee pain is associated with a Worker's Compensation Claim.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Efficacy of Synvisc-One® (Hylan G-F 20) as Adjunctive Therapy for Patients With Knee Osteoarthritis (OA) Requiring Physical Therapy
The study hypothesis is that the use of Synvisc-One will improve physical therapy compliance and performance, resulting in improved knee function and pain when compared to a group that receives a sham injection (an injection that does not have medicine) only before a standardized physical therapy regimen over 10 weeks.
Read the detailed description
This is a prospective, randomized, double-blind (subject and physical therapist), sham needle injection controlled, single center, multi-site study.
Subjects with primary osteoarthritis knee pain will be randomly assigned to a 6 ml intra-articular injection of Synvisc-One or sham needle injection.
The post-treatment course of physical therapy will begin between Day 3 and Day 14 and will last up to 12 weeks in duration (PT ends at study Week 12). Subjects are encouraged to complete between 6 and 16 physical therapy visits within 10-12 weeks of physical therapy treatment as determined by the treating Physical Therapist.
- Conditions
- Knee Osteoarthritis
- Being tested
- Synvisc-One Injection, Sham Injection
- Keywords
- Knee Osteoarthritis, Knee Pain, Synvisc-One
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc-One InjectionDevice
Sham InjectionOther
| Study group | Role | What they receive |
|---|---|---|
| Sham injection | Sham comparator | Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis. Receives: Other: Sham Injection |
| Synvisc-One Injection | Active comparator | Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events. Receives: Device: Synvisc-One Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Pain Score Between Groups
The primary objective of this study is the inter-group difference in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain subscale score over 12 and 24 weeks in subjects diagnosed with primary knee OA that are treated with standardized PT and Synvisc-One versus those that are treated with standardized PT and a sham injection.
The scale range is 0-100 with a higher score being better. The pain scale is a subscale of the overall KOOS, and there are no smaller subscales described or used to create this score.
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startAug 2012
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Enrollment Goals not met
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elaine Husni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elaine Husni, The Cleveland Clinic
- Investigators
- Elaine Husni, MD MPH, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029703
- Sponsor's protocol ID
- CC-GENZYME-2012
- Status last verified
- Mar 2017
- First submitted
- 6 Jan 2014
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Synvisc-One® (Hylan G-F 20) as Adjunctive Therapy for Patients With Knee Osteoarthritis (OA) Requiring Physical Therapy
- ClinicalTrials.gov ID
- NCT02029703
- Acronym / sponsor ID
- CC-GENZYME-2012
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Knee Pain, Synvisc-One
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment Goals not met
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Elaine HusniUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study hypothesis is that the use of Synvisc-One will improve physical therapy compliance and performance, resulting in improved knee function and pain when compared to a group that receives a sham injection (an injection that does not have medicine) only before a standardized physical therapy regimen over 10 weeks.
Detailed description
This is a prospective, randomized, double-blind (subject and physical therapist), sham needle injection controlled, single center, multi-site study.
Subjects with primary osteoarthritis knee pain will be randomly assigned to a 6 ml intra-articular injection of Synvisc-One or sham needle injection.
The post-treatment course of physical therapy will begin between Day 3 and Day 14 and will last up to 12 weeks in duration (PT ends at study Week 12). Subjects are encouraged to complete between 6 and 16 physical therapy visits within 10-12 weeks of physical therapy treatment as determined by the treating Physical Therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham injection | Sham comparator | Other: Sham InjectionSubjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis. |
| Synvisc-One Injection | Active comparator | Device: Synvisc-One InjectionSubjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects meeting the American College of Rheumatology (ACR) criteria for primary knee OA who are age 21 or greater with radiographic and symptomatic evidence of tibio-femoral OA for more than 6 months (unilateral, single joint, Kellgren-Lawrence Grading Scale Score of 2 or 3, medial or lateral +/- patellofemoral).
- Subjects with persistent target knee OA pain despite treatment ≥ 3 months with acetaminophen 4 grams or less or other OA pain treatments.
- Subjects willing to discontinue all prohibited treatments and medications (e.g. opioids, narcotic analgesics, Tramadol) throughout the study period.
- Subjects currently on prescription strength NSAIDs (Non steroidal antiinflammatory drugs) must maintain a stable regimen (no dose increase and no new analgesics) during the entire study period.
- Female subjects of child bearing potential must have a negative serum or urine pregnancy test prior to Synvisc-One® or sham injection.
Key exclusion criteria (36 listed)
- Kellgren-Lawrence Grading Scale score of Grade 1 or Grade 4 given the low efficacy of viscosupplements in this population and the KOOS is not validated in this patient population.
- Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs, feathers, down, or poultry.
- History of viscosupplementation in the target knee joint within 3 months of the baseline visit.
- Isolated patellofemoral OA or isolated anterior knee pain (patellofemoral OA coexisting with tibiofemoral knee OA may be included).
- Symptomatic bilateral knee OA (unless the contralateral knee involvement is limited to radiographic OA and not symptomatic).
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 Injection | Device | Synvisc-One Injection |
| Sham Injection | Other | Sham injection |
Primary outcome
Difference in Pain Score Between Groups
Time frame: 12 and 24 weeks
The primary objective of this study is the inter-group difference in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain subscale score over 12 and 24 weeks in subjects diagnosed with primary knee OA that are treated with standardized PT and Synvisc-One versus those that are treated with standardized PT and a sham injection. The scale range is 0-100 with a higher score being better. The pain scale is a subscale of the overall KOOS, and there are no smaller subscales described or used to create this score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- 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.
Elaine Husni, MD MPH principal investigator
The Cleveland Clinic
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 Injection in people with Knee Osteoarthritis, run by Elaine Husni 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 8 inclusion and 36 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 21 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 21 Apr 2017). 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?
Difference in Pain Score Between Groups (time frame: 12 and 24 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 21 Apr 2017.