II Orthopaedic Clinic, Rizzoli Orthopaedic Institute
Bologna, Emilia-Romagna, 40136, Italy
NCT Number: NCT02629380
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.
Looking for future studies?
Notify Me18 year–50 year
All sexes
Interventional
Phase 4
Bologna, Emilia-Romagna, 40136, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy
The patients randomized in this group will receive arthroscopic meniscectomy alone
Time frame: basal, 15,30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: 15 days
Time frame: 30 days
Time frame: 60 days
Istituto Ortopedico Rizzoli
Other
Early Viscosupplementation After Partial Meniscectomy: a Double Blind, Placebo Controlled Randomized Trial
Acronym: HA-MEN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07476508
Knee Injuries, Leg Injuries
Bydgoszcz, Poland
View Trial DetailsNCT03968029
Meniscus Lesion
Lausanne, Canton of Vaud, Switzerland
View Trial DetailsNCT06475963
Arthritis, Joint Diseases
Bologna, Italy
View Trial DetailsNCT04153643
Meniscus Lesion
Amherst, New York, United States
View Trial Details