Skip to main content
Clinical Trials/ACTRN12616001504404
ACTRN12616001504404
Completed
未知

ongitudinal Study in Knee Osteoarthritis (OA) of Benchmarking Clinical Response and State-attainment following Viscosupplementation with SYNVISC-ONE (LOBRAS Study)

The University of Queensland0 sites130 target enrollmentOctober 31, 2016

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
The University of Queensland
Enrollment
130
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 31, 2016
End Date
TBD
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials