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

Quality of life, physical activity and satisfaction of patients after intra-articular injection of hyaluronic acid with mobile reticulum for the treatment of chondral injury of the knee due to osteoarthritis due to overuse and/or in the conservative treatment of the meniscus injury

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN39292293
Enrollment
178
Registered
2023-05-11
Start date
2018-12-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis, meniscal tear Musculoskeletal Diseases

Interventions

The study recruited patients over 18 years of age, of both sexes, who have undergone intra-articular treatment with mobile reticulum hyaluronic acid for chondral knee injury due to mild to moderate kn

Sponsors

Centre de Tecnificació Esportiva de la Residencia Blume
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026