Health outcomes following SYNVISC-ONE in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis (Knee); Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12616001504404
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

a.Scheduled for SYNVISC ONE therapy.
bMale or female subjects, 30 to 90 years of age, inclusive.
c.Clinical history of symptomatic knee OA.
d.Radiographic evidence of knee OA. (Kellgren and Lawrence (K-L) Scale Grade I-III).
e.Fluent in English.
f.Willing and able to provide written informed consent.
g.Baseline pain score in study knee on a single VA global pain rating scale of between 35mm to 90mm (0-100mm scale).

Exclusion Criteria

a.History of gout or episodes of pseudogout in the study joint.
b.History of rheumatoid arthritis or psoriatic arthritis.
c.Kellgren and Lawrence Grade IV OA radiographs.
d.Previous treatment with viscosupplementation in the last six months.
e.Contraindications to SYNVISC ONE treatment as outlined in the product monograph.

Study & Design

• Study Type: Observational
• Study Design: Not specified