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Patients did not meet inclusion criteria.
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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The investigators' objective is to analyze a group of patients who have had a partial meniscectomy but continue to have knee pain after surgery with a double-blind, randomized prospective study comparing the use of Hylan G-F 20(single injection of a viscosupplementation) versus placebo injection. The investigators would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.
A great majority of patients who have a partial menisectomy for mechanical symptoms do well with full return of function without pain. There is a sub-group of patients who are found to have Grade II- III chondromalacia lesions (deemed arthritic) at the time of surgery that have persistent generalized "arthritic-type" pain despite relief of their mechanical symptoms. To date, there are no published studies analyzing if this treatment is better than no treatment in this group of patients. We would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hylan G-F 20 | Experimental | Single injection of Hylan G-F 20 into the affected knee. |
|
| Sham Injection | Sham Comparator | A needle will be inserted through the knee capsule but no medication will be injected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylan G-F 20 | Drug | 6 ml intra-articular injection given once. The injection takes approximately 15 seconds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS pain scale | 0, 2, 6, 12, 18, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score | 0, 2, 6, 12, 18, 26 weeks | |
| SF-36® Health Survey | 0, 2, 6, 12, 18, 26 weeks | |
| Physical Examination |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grant Jones, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Sports Medicine Center | Columbus | Ohio | 43221 | United States |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C049816 | hylan |
| C005703 | salicylhydroxamic acid |
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| Sham Injection | Other | A needle will be inserted through the knee capsule but no medication will be injected. |
|
| 0, 2, 6, 12, 18, 26 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |