Routine Application of Ostenil® Mini in Patients with Rhizarthrosis

TRB Chemedica

Status

Completed

Conditions

Rhizarthrosis

Treatments

Device: Ostenil® Mini

Study type

Observational

Funder types

Industry

Identifiers

NCT03879434

OSTCMC-PMCF-DE-2018-01

Details and patient eligibility

About

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

Enrollment

110 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® Mini recommendation for the treatment of rhizarthrosis

Exclusion criteria

Known hypersensitivity to one of the Ostenil® Mini components
Known pregnancy or lactating females
Presence of coagulation disorder
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)