Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis

TRB Chemedica

Status: Completed

Conditions: Coxarthrosis

Treatments: Device: Ostenil® Plus

Study type: Observational

Funder types: Industry

Identifiers

NCT03809962

OSTH-PMCF-DE-2018-01

Details and patient eligibility

About

PMCF study to observe the Routine application of Ostenil® Plus in the Treatment of pain and restricted mobility in degenerative and traumatic changes of the Hip Joint.

Enrollment: 170 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects ≥ 18 years of age and in good general health condition
2. Signed informed consent
3. Existing Ostenil® Plus recommendation for the treatment of coxarthrosis

Exclusion criteria

1. Known hypersensitivity to one of the OSTENIL® PLUS components
2. Known pregnancy or lactating females
3. Previous/concomitant participation in clinical investigation within the last 3 months prior to study inclusion
4. 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
5. 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

170 participants in 1 patient group

Ostenil® Plus

Description:

1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval.

Treatment:

Device: Ostenil® Plus