Knee osteoarthritis, meniscal tear Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Quality of life (QoL) determined using several instruments, including the KOOS score, WOMAC score, Patient's Global Improvement Impression Scale (PGI-I), ad hoc QoL single question 2. Physical activity determined using specific sub-dimensions from KOOS: activities of daily living (ADL), sport and recreation (Sport/Rec) 3. Satisfaction with the HA treatment evaluated using a visual analogue scale of satisfaction and an ad-hoc questionnaire Measured at 1, 2 and 3 months for the MT group and 1, 2, 3 and 6 months for the KOA and mixed group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain in the previous 7 days to the visit measured using the VAS score 2. Local tolerability at the site of injection of the viscosupplementation product assessed through retrospective collection considering redness and pain occurring in the minutes following treatment sessions 3. Systemic adverse events recorded during the follow-up visits Measured at 1, 2 and 3 months for the MT group and 1, 2, 3 and 6 months for the KOA and mixed group | — |
Countries
Spain