Routine Application of Ostenil® in Patients with Gonarthrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-08

Study Completion Date

2023-01-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Gonarthrosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Ostenil®

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

Ostenil®

Intervention Type DEVICE

Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation.

Interventions

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Ostenil®

Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No