Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

• Status: Withdrawn
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grant Jones
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Hyaluronic Acid; Hylan

Criteria

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