Routine Application of Ostenil® Mini in Patients With Rhizarthrosis

Rhizarthrosis Clinical Trial

Official title:

Routine Application of Ostenil® Mini in Patients With Rhizarthrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03879434
• Other study ID #: OSTCMC-PMCF-DE-2018-01
• Status: Recruiting
• Start date: April 2, 2019
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: TRB Chemedica AG
• Contact: Raphaela Geiger
• Phone: +49 89 461483-27
• Email: geiger[@]trbchemedica.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• 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® 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)

Related Conditions & MeSH terms

• Osteoarthritis
• Rhizarthrosis

Intervention

Device:
• Ostenil® Mini
Ostenil® Mini 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 Berlin Freiheit 1	Berlin
Germany	Orthopädie am Kiesteich	Berlin
Germany	Orthopädie am Tauentzien	Berlin
Germany	Orthopädie Wannsee	Berlin
Germany	Praxis für Orthopädie und Unfallchirurgie	Berlin
Germany	Wirbelsäulen Gelenk Zentrum Westend	Berlin

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 equal the worst pain)	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Primary	Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline	Functional Index for Hand OsteoArthritis (FIHOA) to assess hand-OA related functional impairment on a 4-grade scale	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Primary	Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline	Questionnaire to assess hand-OA related Quality of Life on a 5-grade scale	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
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 84 after last injection, Day 168 after last injection
Primary	Incidence of Treatment-Emergent Adverse Events		Up to Day 252 after the last injection
Primary	Change of Key Pinch Strength compared to Baseline (Pinch Gauge)	Measurement of Key Pinch in kilograms with a Pinch Gauge	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Primary	Change of Tip Pinch Strength compared to Baseline (Pinch Gauge)	Measurement of Tip Pinch in kilograms with a Pinch Gauge	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Primary	Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)	Measurement of Palmar Pinch in kilograms with a Pinch Gauge	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection