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Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

WithdrawnNA

Sponsor: Grant Jones

Conditions: Arthralgia

Interventions: Hylan G-F 20, Sham Injection

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Columbus, Ohio, United States