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Does Fermatron plus improve pain and functioning in patients with knee OA compared to placebo?

Does Fermatron plus improve pain and functioning in patients with knee OA compared to placebo? - Fermathron plus versus placebo

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31817
Enrollment
200
Registered
2009-02-26
Start date
2009-06-30
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

degenerative joint disease Osteoarthritis

Interventions

Included patients are randomised to either the treatment group (3 injections with Fermathron plus) or to the placebo group (3 injections with saline)

Sponsors

Sint Annaziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Mild osteoarthritis of the knee, Kellgren-Lawrence grade I-III

Exclusion criteria

Exclusion criteria: Bilateral osteoarthritis of the knee Pregnancy Lactation Infection of the knee evidence of skin disease

Design outcomes

Secondary

MeasureTime frame
1. Patient satisfaction with the applied treatment 2. Safety of the applied treatment. 3. Range of motion in the affected knee

Primary

MeasureTime frame
1. Pain in the affected knee 2. Restricions in daily activities due to the affected knee

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)