Routine Application of Ostenil® in Patients with Gonarthrosis

TRB Chemedica

Status: Completed

Conditions: Gonarthrosis

Treatments: Device: Ostenil®

Study type: Observational

Funder types: Industry

Identifiers

NCT03734315

OSTK-PMCF-DE-2018-01

Details and patient eligibility

About

PMCF study to observe the routine application of Ostenil® in the treatment of pain and restricted mobility in degenerative and traumatic changes of the knee joint.

Enrollment: 115 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects ≥ 18 years of age and in good general health condition
• Signed informed consent
• Existing Ostenil® recommendation for the treatment of gonarthrosis

Exclusion criteria

• Known hypersensitivity to one of the Ostenil® components
• Presence of articular effusion in study-relevant knee joint
• Known pregnancy or lactating females
• Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts
• Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)

Trial design

115 participants in 1 patient group

Ostenil®

Description:

3-5 injections of sodium hyaluronate 1 % (20 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.

Treatment:

Device: Ostenil®