Routine Application of Ostenil® Mini in Patients With Rhizarthrosis

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.

Study Overview

• Status: Recruiting
• Conditions: Rhizarthrosis
• Intervention / Treatment: Device: Ostenil® Mini

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Raphaela Geiger; Phone Number: +49 89 461483-27; Email: geiger@trbchemedica.de
• Study Contact Backup: Name: Lucia Hopp; Phone Number: +49 89 461483-29; Email: hopp@trbchemedica.de

Study Locations

• Germany
  • Berlin, Germany, 10711
    • Recruiting
    • Praxis für Orthopädie und Unfallchirurgie
    • Contact: Bernd Hüske, Dr. med.
  • Berlin, Germany, 10789
    • Active, not recruiting
    • Orthopädie am Tauentzien
  • Berlin, Germany, 12555
    • Completed
    • MVZ Berlin Freiheit 1
  • Berlin, Germany, 13589
    • Active, not recruiting
    • Orthopädie am Kiesteich
  • Berlin, Germany, 14052
    • Completed
    • Wirbelsäulen Gelenk Zentrum Westend
  • Berlin, Germany, 14109
    • Active, not recruiting
    • Orthopädie Wannsee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult Patients with Rhizarthrosis and a Recommendation for Treatment with Ostenil® Mini.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ostenil® Mini; 1-3 injections of sodium hyaluronate 1.0 % (10 milligrams (mg) / 1,0 millilitres (ml)) in weekly interval.	Device: Ostenil® Mini; Ostenil® Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events		Up to Day 252 after the last injection
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: TRB Chemedica AG

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: OSTCMC-PMCF-DE-2018-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No