NCT02629380

Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial

Early Viscosupplementation After Partial Meniscectomy: a Double Blind, Placebo Controlled Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The rational of intra-articular viscosupplementation is based on both the biological and mechanical properties of HA, which exerts positive effects on the modulation of the entire joint environment. The aim of the present double blind controlled study was to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of HA performed at the end of arthroscopic partial meniscectomy. Patients included in this trial were randomized in two treatment groups: the first one received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy) at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery alone. All patients were evaluated basally, at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.

Conditions

• Meniscus Lesion

Interventions

Type	Name	Description
BIOLOGICAL	hyaluronic acid	A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy
PROCEDURE	meniscectomy alone	The patients randomized in this group will receive arthroscopic meniscectomy alone

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-12-14
• Last updated: 2017-09-13

Locations

1 site across 1 country: Italy