Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Arthralgia

In brief

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.

Key facts

Study ID

NCT00971074

Run by

Grant Jones

People needed

0

Starts

2009-12-01

Expected to finish

2011-12-01

Last updated by the study team

2021-02-25

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• The Ohio State University Sports Medicine Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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