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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00949494 |
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Date of registration:
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29/07/2009 |
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Primary sponsor: |
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Public title:
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Effects of Synvisc on Cartilage in Knee Osteoarthritis (OA)
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Scientific title:
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Pilot Trial of Effects of Intra-articular Synvisc Therapy on Cartilage Determined by dGEMRIC in Patients With OA of the Knee |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00949494 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Pottumarthi V Prasad, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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NorthShore University HealthSystem |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Device: Synvisc
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Primary Outcome(s)
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Percent change in dGEMRIC Index (T1(Gd)) in femoral and tibial compartments
[Time Frame: 3 and 6 months]
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Secondary Outcome(s)
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Subjects' global assessment of disease using a 10 point Likert scale
[Time Frame: 3 and 6 months]
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Secondary ID(s)
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EH 06-159
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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