Arthralgia Clinical Trial
Official title:
The Use of Viscosupplementation for the Treatment of Patients With Persistent Non-mechanical Pain Status-post Partial Menisectomy
NCT number | NCT00971074 |
Other study ID # | 2009H0156 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2009 |
Est. completion date | December 2011 |
Verified date | February 2021 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age 18-60 - S/P partial medial and/or lateral partial meniscectomy - Pre-operative MRI diagnosed meniscal tear - Diffuse, non-focal arthroscopically diagnosed ICRS Grade II or III chondromalacia. (used to determine the presence of tibiofemoral osteoarthritis) - Baseline VAS pain score between 50 and 80mm. - Persistent, generalized knee pain without mechanical symptoms - Kellgren/Lawrence (K/L) grade II or III (used to determine the presence of tibiofemoral osteoarthritis) Exclusion Criteria: - Bilateral arthroscopy (within 6 months pre- and post- initial VAS score. - Complete meniscectomy - Microfracture (via drilling, picking, abrading, thermal or radiofrequency or any procedure that violates the subchondral plate) - Focal chondral lesion visualized on arthroscopy or any focal cartilage procedure (e.g. ACI, OATS, mosaicplasty, etc) - Concomitant ligamentous injury or repair - K/L stage I or IV - Significant Varus or Valgus clinical malalignment - S/P tibial osteotomy in target knee - Isolated patello-femoral OA or isolated anterior knee pain - Prosthetic implant in either knee - Re-injury in time between original surgery and baseline visit - Inflammatory arthritis (e.g. rheumatoid arthritis, gout, pseudogout (chondrocalcinosis), lupus, etc) - Obesity with BMI > 35 (at time of initial VAS score - NSAIDs or opiates within one week of baseline randomization or during trial period - Known allergy to viscosupplements, known allergy to avian, egg or feather products - Prior Viscosupplementation use in ipsilateral knee - Oral steroids (within 4 weeks of initial VAS score) - IA steroids in target knee within 6 months - Significant medical co-morbidities ( e.g. malignancy, hepatic, renal, cardiac, pulmonary, gastrointestinal disease) in the judgment of the investigator - Known hip disease - Pregnant or nursing (at time of injection, pregnancy test at visit) - Active infection of either lower extremity or past history of septic arthritis - Venous or lymphatic stasis in either lower extremity - Enrolled in clinical trial within 3 months of baseline - Contralateral knee arthritis |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Sports Medicine Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Grant Jones | Genzyme, a Sanofi Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS pain scale | 0, 2, 6, 12, 18, 26 weeks | ||
Secondary | Knee injury and Osteoarthritis Outcome Score | 0, 2, 6, 12, 18, 26 weeks | ||
Secondary | SF-36® Health Survey | 0, 2, 6, 12, 18, 26 weeks | ||
Secondary | Physical Examination | 0, 2, 6, 12, 18, 26 weeks |
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