Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial

Phase 4

Completed

• Conditions: Meniscus Lesion
• Interventions: Biological: hyaluronic acid; Procedure: meniscectomy alone

• Registration Number: NCT02629380
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-14
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid group	hyaluronic acid	Single injection of 3 ml HA (Hymovis, Fidia Farmaceutici SpA, Padova, Italy) at the end of the arthroscopic meniscectomy
meniscectomy alone	meniscectomy alone	Arthroscopic meniscectomy alone

Primary Outcome Measures

Name	Time	Method
Change in IKDC (International Knee Documentation Committee) score	basal, 15,30,60,180 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

II Orthopaedic Clinic, Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Emilia Romagna, Italy