NCT02629380: HA-MEN

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

Completed Phase 4 Last updated 12 September 2017

What this trial tests

Phase 4 trial testing hyaluronic acid in Meniscus Lesion in 90 participants. Completed in 1 May 2016.

Timeline

1 December 2012

Primary endpoint
1 May 2016

1 May 2016

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	90
Start date	1 December 2012
Primary completion	1 May 2016
Estimated completion	1 May 2016
Sites	1 location across Italy

Drugs / interventions tested

• hyaluronic acid (HYALURONIC ACID) — full drug profile →
• meniscectomy alone

Conditions studied

• Meniscus Lesion — all drugs for Meniscus Lesion →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

Adults 18 to 50, any sex, with Meniscus Lesion. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in IKDC (International Knee Documentation Committee) score
  Time frame: basal, 15,30,60,180 days

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. No Effects of Early Viscosupplementation After Arthroscopic Partial Meniscectomy: A Randomized Controlled Trial.
   Filardo G, Di Matteo B, Tentoni F, Cavicchioli A, et al · · 2016 · cited 17× · PMID 27528611 · DOI 10.1177/0363546516660070