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Analysis of clinical and radiological factors in Viscosupplementation treatment (Hyaluronic Acid + Sorbitol) in patients with knee Arthrosis: prospective cohort study

Analysis of clinical and radiological factors as predictors of response to Viscosupplementation (Hyaluronic Acid + Sorbitol) in patients with knee Osteoarthritis: prospective cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-35td3p
Enrollment
Unknown
Registered
2020-11-20
Start date
2019-11-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Gonarthrosis (knee osteoarthritis)

Interventions

All patients will be submitted to viscosupplementation with 80 mg of hyaluronic acid and 160 mg of sorbitol (Synolis-VA® 4.0 ml) single dose intra-articular injection
And all patients will undergo radiography of the knee AP and Profile with load once only on the same date of viscosupplementation. All patients will be evaluated by the WOMAC, SF-12 and EVA questionna
Drug
Radiation
E02.718.875

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Ortocity
Collaborator

Eligibility

Age
45 Years to 120 Years

Inclusion criteria

Inclusion criteria: Osteoarthritis grade 1 to 4 Kellgren and Lawrence. Magnetic resonance Imaging of the knee 1.5 T performed up to 3 months before viscosupplementation. Failure of conservative treatment for knee osteoarthrosis: pain > 5 on Visual Analogue Scale on walk after 30 days of performed standardized physiotherapy 10 sessions and simple analgesia.

Exclusion criteria

Exclusion criteria: Magnetic resonance imaging with insufficient protocol or inadequate technique. Radiographies with inadequate technique. Non-inclusion criteria: Systemic inflammatory disease; Diagnosis of other orthopedic conditions in the affected lower limb; Viscossupplementation or other infiltration in the affected knee performed up to 12 months prior to the study; Corticosteroids in the last 6 months; History of previous allergy to Hyaluronic acid or Sorbitol; Pregnant;

Design outcomes

Primary

MeasureTime frame
The main outcome is the improvement in physical function after viscosupplementation, assessed by the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire (WOMAC), compared immediately before, two weeks, three months and six months after.;SF-12v2® Health Survey Standard, physical and mental health scale, performed immediately before, two weeks, three months and six months after viscosupplementation.;Pain intensity assessed by visual analog scale (VAS), performed immediately before, two weeks, three months and six months after viscosupplementation.

Secondary

MeasureTime frame
Semiquantitative score for knee osteoarthritis according to the criteria defined by the MRI Osteoarthritis Knee Score (MOAKS) before viscosupplementation;Angle of the femorotibial axis on radiography;Kellgren Lawrence Classification on radiography;Volume of Articular effusion immediately before viscosupplementation;Body mass index (BMI);Previous knee surgery

Countries

Brazil

Contacts

Public ContactGustavo Pinto

Universidade Federal de São Paulo

gustavo.rossanese@gmail.com+55-11-972498306

Outcome results

None listed

Source: REBEC (via WHO ICTRP)