Effects of Synvisc on Cartilage in Knee Osteoarthritis (OA)

This study has been completed.
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Northwestern University
Information provided by:
NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT00949494
First received: July 29, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative used to treat knee osteoarthritis (OA). Animal studies have shown that Synvisc can have favorable effects on cartilage when injected into joints. This study attempts to evaluate the effects of Synvisc when injected into knees of patients with knee OA by means of a specialized MRI technology (dGEMRIC).


Condition Intervention Phase
Osteoarthritis
Device: Synvisc
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pilot Trial of Effects of Intra-articular Synvisc Therapy on Cartilage Determined by dGEMRIC in Patients With OA of the Knee

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Percent change in dGEMRIC Index (T1(Gd)) in femoral and tibial compartments [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects' global assessment of disease using a 10 point Likert scale [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2006
Study Completion Date: February 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Synvisc Device: Synvisc
intra-articular, 3 weekly injections
Other Name: hyaluronan
Placebo Comparator: Placebo Device: Synvisc
intra-articular, 3 weekly injections
Other Name: hyaluronan

Detailed Description:

Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative which is administered by injection into osteoarthritic joints for the treatment of osteoarthritis. Preclinical investigations have demonstrated that Hylan G-F 20 can favorably affect chondrocyte metabolism and recent clinical studies [Ann Rheum Dis. 2004 May;63(5):478-82; Osteoarthritis Cartilage. 2005 Mar;13(3):216-24] provide support for a disease-modifying effect of Hylan G-F 20 therapy. This study will utilize dGEMRIC imaging of patients with knee OA to assess the effects of Hylan G-F 20 therapy on cartilage in vivo over time. Delayed Gadolinium Enhanced MRI of the Cartilage (dGEMRIC) permits a quantitative assessment of GAG distribution within intact cartilage in vivo. Since dGEMRIC is noninvasive, the technique may be useful to non-invasively monitor the influence of various treatments on hyaline cartilage.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females 40 to 80 years of age who meet the ACR Criteria for osteoarthritis of the knee.
  2. Radiographic evidence of OA, Kellgren and Lawrence grade I to III on prior X-rays (taken within 6 months of the screening visit) or at screening. Only the tibio-femoral joint will be evaluated (patello-femoral disease will not be considered).
  3. Mild to moderate levels of knee pain as determined by a VAS pain score of 3-6/10 that has been stable for at least 1 month prior to screening visit.
  4. Stable management regimen for knee OA pain for at least 1 month prior to screening visit. Subjects can be managed by physical measures alone, simple analgesics, NSAIDs, nutriceuticals or other agents with no significant change in treatment regimen during the 1 month prior to screening visit.
  5. Ability to comply with the requirements of the study
  6. Able to maintain stable exercise/activity program during course of the study

6. Signed and dated consent form 7. Women of child-bearing potential should agree to the use of an appropriate method of contraception and have a confirmed negative pregnancy test at screening.

Exclusion Criteria:

  1. Radiographic evidence of Kellgren and Lawrence grade IV OA
  2. Knee pain <3 or >6 out of 10 on VAS pain scale.
  3. Change in management regimen for knee OA during the preceding month.
  4. Subjects with any metal implant such as cardiac pacemakers, spinal cord stimulators or bionic ear devices.
  5. Subjects who are unable to receive gadolinium contrast agent injection because of contraindications.
  6. Unable to undergo an MRI exam because of contraindication, e.g. claustrophobia.
  7. Inflammatory arthritis, e.g. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus.
  8. History of other diseases that may involve the study joint including inflammatory joint disease, crystalline disease, endocrinopathies, metabolic disease, knee infection of the chosen knee, neuropathic disorders, avascular necrosis, Paget's disease or tumors
  9. Recent trauma to study joint.
  10. Known loose bodies in the study joint.
  11. Patients taking oral steroids.
  12. Patients with active malignancy.
  13. Patients who are either high-performance athletes or, in the opinion of the investigator, are highly sedentary and not likely to ambulate at least 20-30 minutes/day.
  14. In the opinion of the investigator, the subject has an unstable medical condition.
  15. Participating in another study or has participated in a study evaluating investigational drugs, devices or biologics within three months of enrollment in this study.
  16. Study subject has ever previously received hyaluronan therapy.
  17. Arthroscopic or open surgery to the study joint within the previous twelve months.
  18. Anticipated need for knee surgery to the study joint.
  19. History of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the study knee.
  20. Intra-articular injection of corticosteroid to study joint within the past six months.
  21. Morbid obesity defined as BMI of greater than 40.
  22. Study subject has known sensitivity to any component of Hylan G-F 20 including bird feathers, eggs or poultry.
  23. Subject has an active systemic infection.
  24. Subject on coumadin or other anticoagulant.
  25. Musculoskeletal pain that may preclude the subject from remaining motionless for the MRI exam.
  26. Women who are pregnant or lactating.
  27. Subjects with "clinically significant" malalignment.
  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: NCT00949494

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Northshore University Hospital
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Genzyme, a Sanofi Company
Northwestern University
Investigators
Principal Investigator: Pottumarthi V Prasad, PhD NorthShore University HealthSystem
  More Information

No publications provided

Responsible Party: Pottumarthi V. Prasad, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT00949494     History of Changes
Other Study ID Numbers: EH 06-159
Study First Received: July 29, 2009
Last Updated: July 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
knee osteoarthritis, synvisc, hyaluronan, dGEMRIC,cartilage

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
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 August 26, 2014