Evaluation of quality of life following treatment with Hymovis in patients with knee osteoarthritis and/or meniscal tear

Not Applicable

Completed

• Conditions: Knee osteoarthritis, meniscal tear; Musculoskeletal Diseases

• Registration Number: ISRCTN39292293
• Lead Sponsor: Centre de Tecnificació Esportiva de la Residencia Blume

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-30
• Study Start: 2023-05-11
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

The study population comprised patients (male or female) older than 18 years seen at one of the participating clinics between December 2018 and July 2019 for their first follow-up visit after intra-articular injection of mobile reticulum hyaluronic acid due to:
1. Mild to moderate symptomatic knee osteoarthritis responding to clinical and radiological criteria of American College of Rheumatology (ACR) and a Kallgren and Lawrence (KL) score II/III evidenced by radiography and/or MRI. Patients received two consecutive intra-articular injections of HYMOVIS (3 ml syringe with 8 mg of non-cross-linked HA alkylamida HYADD4; FIDIA Farmaceutici, Italy) given at 1-week intervals according to the prospect.
2. Knee meniscal tear (traumatic or degenerative) objectifiable by radiography and/or MRI. Patients received two consecutive intra-articular injections of HYMOVIS given at 2-week intervals according to the prospect.
3. Mild to moderate symptomatic knee osteoarthritis with meniscal tear. Patients received two consecutive intra-articular injections of HYMOVIS given at 1-week intervals according to the prospect.

Exclusion Criteria

1. Viscosupplementation or corticosteroid therapy in the last 6 months
2. Concomitant diseases that could interfere with the tests during the data collection period or that could lead to erroneous results (i.e., rheumatoid arthritis, metabolic bone diseases, gout, Paget's disease of bone, symptomatic chondrocalcinosis)
3. Knee arthroplasty or other knee surgery in the last 12 months
4. Any scheduled surgery during the data collection period
5. Evidence or suspicion of infection in the affected joint or skin diseases of the knee, such as dermatitis or psoriasis
6. Patients with bilateral knee OA

Study & Design

• Study Type: Observational
• Study Design: Not specified