Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of Viscosupplementation for the Treatment of Patients With Persistent Non-mechanical Pain Status-post Partial Menisectomy

Conditions
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Arthralgia

Intervention / Treatment
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* Drug: Hylan G-F 20
* Other: Sham Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hylan G-F 20<br>Single injection of Hylan G-F 20 into the affected knee. | Drug: Hylan G-F 20<br>* 6 ml intra-articular injection given once. The injection takes approximately 15 seconds.<br>* Other names: Synvisc One;|
| Sham Comparator: Sham Injection<br>A needle will be inserted through the knee capsule but no medication will be injected. | Other: Sham Injection<br>* A needle will be inserted through the knee capsule but no medication will be injected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain scale |  | 0, 2, 6, 12, 18, 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 0, 2, 6, 12, 18, 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthralgia, Viscosupplementation, Knee, Menisci, Tibial, Surgery, Outpatient