Synvisc-One for Younger, Active Patients With Osteoarthritis (SYNVISC-ONE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01625013
First received: June 11, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Osteoarthritis
Device: Synvisc-One (G-F 20)

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Management of "Younger, Active" Patients With Pain From Early Knee Osteoarthritis With Synvisc-One (Hylan G-F 20)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Decreased pain [ Time Frame: 26 weeks post-injection through 3 years post-injection ] [ Designated as safety issue: No ]
    To identify whether injection of 6 mL hylan G-F 20 decreases pain over 26 weeks in young (ages 30 to 50 years) active patients with symptomatic primary osteoarthritis of the knee not treated previously with hylan G-F 20.


Secondary Outcome Measures:
  • The effect of repeated treatments [ Time Frame: 26 weeks post-injection through 3 years post-injection ] [ Designated as safety issue: Yes ]
    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.

  • Identify the effects of treatment on activity levels [ Time Frame: 26 weeks post-injection through 3 years post-injection ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synvisc-One Device: 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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625013

Contacts
Contact: Caroline Currie, MA 415 353 7987 Curriec@orthosurg.ucsf.org
Contact: Anthony Luke, MD 415-885-3807 LukeA@orthosurg.ucsf.edu

Locations
United States, California
University of California Recruiting
San Francisco, California, United States, 94158
Contact: Caroline Currie    415-353-7987    CurrieC@orthosurg.ucsf.edu   
Contact: Catherine Cook    415-514-6120    catherine.cook@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Anthony Luke, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01625013     History of Changes
Other Study ID Numbers: UCSF-SYNVISC-ONE 001
Study First Received: June 11, 2012
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
osteoarthritis
viscosupplementation
Active
Knee
Synvisc-One

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014