Routine Application of Ostenil® Mini in Patients With Rhizarthrosis

Completed

• Conditions: Rhizarthrosis
• Interventions: Device: Ostenil® Mini

• Registration Number: NCT03879434
• Lead Sponsor: TRB Chemedica AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Study Start: 2019-04-17
• Primary Completion: 2024-05-16
• Study Completion: 2024-05-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ostenil® Mini	Ostenil® Mini	1-3 injections of sodium hyaluronate 1.0 % (10 milligrams (mg) / 1,0 millilitres (ml)) in weekly interval.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Up to Day 252 after the last injection
Change of Tip Pinch Strength compared to Baseline (Pinch Gauge)	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	Measurement of Tip Pinch in kilograms with a Pinch Gauge
Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	Measurement of Palmar Pinch in kilograms with a Pinch Gauge
Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	Functional Index for Hand OsteoArthritis (FIHOA) to assess hand-OA related functional impairment on a 4-grade scale
Change of Pain Intensity compared to Baseline (VAS-slider)	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. (10 cm equal the worst pain)
Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	Questionnaire to assess hand-OA related Quality of Life on a 5-grade scale
Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse)
Change of Key Pinch Strength compared to Baseline (Pinch Gauge)	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	Measurement of Key Pinch in kilograms with a Pinch Gauge

Trial Locations

Locations (6)

Praxis für Orthopädie und Unfallchirurgie; 🇩🇪 Berlin, Germany

Orthopädie am Tauentzien; 🇩🇪 Berlin, Germany

MVZ Berlin Freiheit 1; 🇩🇪 Berlin, Germany

Orthopädie am Kiesteich; 🇩🇪 Berlin, Germany

Wirbelsäulen Gelenk Zentrum Westend; 🇩🇪 Berlin, Germany

Orthopädie Wannsee; 🇩🇪 Berlin, Germany