Overview

This trial is active, not recruiting.

Condition meniscus lesion
Treatments hyaluronic acid, meniscectomy alone
Phase phase 4
Sponsor Istituto Ortopedico Rizzoli
Start date December 2012
End date March 2016
Trial size 90 participants
Trial identifier NCT02629380, Rizzoli HA-MEN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Single injection of 3 ml HA (Hymovis, Fidia Farmaceutici SpA, Padova, Italy) at the end of the arthroscopic meniscectomy
hyaluronic acid
A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy
(Other)
Arthroscopic meniscectomy alone
meniscectomy alone
The patients randomized in this group will receive arthroscopic meniscectomy alone

Primary Outcomes

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

Secondary Outcomes

Measure
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)
time frame: basal, 15,30,60,180 days
Change in Tegner Score
time frame: basal, 15,30,60,180 days
Change in VAS (Visual Analogue Scale) for pain
time frame: basal, 15,30,60,180 days
Change in EQ-VAS for general health
time frame: basal, 15,30,60,180 days
Change in transpatellar circumference over time
time frame: basal, 15,30,60,180 days
Change in active and passive ROM
time frame: basal, 15,30,60,180 days
Adverse events report
time frame: 15 days
Adverse events report
time frame: 30 days
Adverse events report
time frame: 60 days

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: 1. chronic symptomatic meniscal tears requiring partial resection; 2. healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint); Exclusion Criteria: 1. previous surgery on the index knee; 2. other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries); 3. history of knee infectious arthritis; 4. concurrent rheumatic, metabolic or severe systemic disease; 5. Body Mass Index (BMI) > 30; 6. known hypersensibility or allergy to/towards HA ; 7. alcohol or other substances abuse/excess.

Additional Information

Official title Early Viscosupplementation After Partial Meniscectomy: a Double Blind, Placebo Controlled Randomized Trial
Principal investigator Elizaveta Kon, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Istituto Ortopedico Rizzoli.