Routine Application of Ostenil® in Patients With Gonarthrosis

Gonarthrosis Clinical Trial

Official title:

Routine Application of Ostenil® in Patients With Gonarthrosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03734315
• Other study ID #: OSTK-PMCF-DE-2018-01
• Status: Active, not recruiting
• Start date: January 8, 2019
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: TRB Chemedica AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Germany	MVZ am Nordbad	München	Bayern
Germany	Orthopädie am Altheimer Eck	München	Bayern
Germany	Orthopädie München	München	Bavaria
Germany	Orthopädische Praxis	München	Bayern
Germany	Orthopädische Praxis am Isartor	München	Bayern
Germany	Orthopädisches Versorgungszentrum München-Ost	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
TRB Chemedica AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pain Intensity compared to Baseline (VAS-slider)	Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. 10 cm equals the worst pain.	Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252
Primary	Change of Range of Motion compared to Baseline (Goniometer measurement)	Assessment of the Range of Extension and Flexion of the Knee Joint using a Goniometer.	Day 7, Day 14, Day 21, Day 28, Day 84, Day 168
Primary	Change of Subjective Therapy Evaluation (KOOS Questionnaire) compared to Baseline	Knee injury and Osteoarthritis Outcome Score (KOOS) to assess Stiffness, Pain, Function (daily living) and Quality of Life on a 5-point Likert scale.	Day 84, Day 168
Primary	Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)	The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse).	Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252
Primary	Incidence of Treatment-Emergent Adverse Events		Up to Day 252