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Completed

NCT Number: NCT03879434

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.

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Key information

Conditions

Rhizarthrosis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopädie am Tauentzien, Berlin, State of Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ostenil® Mini

Device

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

Primary outcomes

  1. Change of Pain Intensity compared to Baseline (VAS-slider)

    Time frame: 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)

  2. Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline

    Time frame: 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

  3. Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline

    Time frame: 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

  4. Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)

    Time frame: 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)

  5. Incidence of Treatment-Emergent Adverse Events

    Time frame: Up to Day 252 after the last injection

  6. Change of Key Pinch Strength compared to Baseline (Pinch Gauge)

    Time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection

    Measurement of Key Pinch in kilograms with a Pinch Gauge

  7. Change of Tip Pinch Strength compared to Baseline (Pinch Gauge)

    Time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection

    Measurement of Tip Pinch in kilograms with a Pinch Gauge

  8. Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)

    Time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection

    Measurement of Palmar Pinch in kilograms with a Pinch Gauge

Sponsors and collaborators

Lead sponsor

TRB Chemedica AG

Industry

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2019
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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