NCT04577521

The Safety and Efficacy of Single IA-HA Injection in Patients With Knee Osteoarthritis: A Prospective Study

Prospective Single Centre Open Label Investigator Initiated Clinical Study to Evaluate the Efficacy and Safety of Cross-linked Intra-Articular Hyaluronic Acid (HA)(Biovisc Ortho Single) in Patients With Knee Osteoarthritis (OA)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Goztepe Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective study was planned to carried out among the patients with grade II and III (Kellgren Lawrence classification) osteoarthritis of the knee attending outpatients clinic to evaluate the effectiveness and safety of viscosupplementation with intra-articular hyaluronic acid injection.

Detailed description

The study was designed as prospective, single-center, single-arm, open-label, observational study. The patients with grade II and III (Kellgren Lawrence classification) osteoarthritis of the knee attending outpatients were planned to enroll the study. Patients between the age 18-80 years who did not achieve remission of pain despite receiving the first-line treatment for gonarthrosis including nonsteroidal anti-inflammatory drugs medication, activity modification and ice, were planned to included in the study. A single dose of HA will be injected into the target knee joint. Clinical evaluation will be done using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the short form-36 questionnaires (SF-36 v2) at baseline, 3 months and 6 months by a clinical secretariat.

Conditions

• Gonarthrosis

Interventions

Type	Name	Description
DEVICE	BioVisc Ortho Single	BioVisc Ortho Single consisted of a prefilled syringe containing 90 mg/3 mL of IA-HA and is an injectable-grade HA from a biofermentation origin. Biovisc ortho single prefilled syringes are intended for single-use only, and the entire content of the syringe was injected into the target joint.

Timeline

• Start date: 2019-03-04
• Primary completion: 2020-01-29
• Completion: 2020-01-29
• First posted: 2020-10-08
• Last updated: 2020-10-14

Locations

1 site across 1 country: Turkey (Türkiye)