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Completed

NCT Number: NCT03809962

Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis

PMCF study to observe the Routine application of Ostenil® Plus in the Treatment of pain and restricted mobility in degenerative and traumatic changes of the Hip Joint.

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Key information

Conditions

Coxarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopädische Praxis Rahlstedt, Hamburg, Free and Hanseatic City of Hamburg, 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® Plus recommendation for the treatment of coxarthrosis

Exclusion criteria

  • Known hypersensitivity to one of the OSTENIL® PLUS components
  • Known pregnancy or lactating females
  • Previous/concomitant participation in clinical investigation within the last 3 months prior to study inclusion
  • 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® Plus

Device

Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % 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 equals the most pain)

  2. Change of Range of Motion compared to Baseline (Goniometer measurement)

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

    Assessment of the Range of internal and exernal rotation of the Hip Joint using a Goniometer.

  3. 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).

  4. Incidence of Treatment-Emergent Adverse Events

    Time frame: Up to Day 252 after the last injection

  5. Change of Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline

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

    Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Pain on a 5-point Likert scale

  6. Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline

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

    Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Stiffness on a 5-point Likert scale

  7. Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline

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

    Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Function in daily living on a 5-point Likert scale

  8. Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline

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

    Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Quality of Life on a 5-point Likert scale

Sponsors and collaborators

Lead sponsor

TRB Chemedica AG

Industry

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2019
Registry last updated
Jun 5, 2025

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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