January 14, 2019
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January 18, 2019
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May 28, 2021
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January 30, 2019
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August 2024 (Final data collection date for primary outcome measure)
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- 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)
- 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.
- 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).
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to Day 252 after the last injection ]
- 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
- 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
- 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
- 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
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Same as current
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Not Provided
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Not Provided
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Not Provided
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Not Provided
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Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
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Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
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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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Not Provided
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Observational
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Observational Model: Other Time Perspective: Prospective
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Not Provided
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Not Provided
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Non-Probability Sample
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Adult patients with Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.
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Coxarthrosis
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Device: Ostenil® Plus
Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation
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Ostenil® Plus
1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval.
Intervention: Device: Ostenil® Plus
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Not Provided
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Recruiting
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250
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50
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August 2024
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August 2024 (Final data collection date for primary outcome measure)
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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)
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Sexes Eligible for Study: |
All |
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18 Years to 99 Years (Adult, Older Adult)
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No
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Contact: Raphaela Geiger |
+49 89 461483-27 |
geiger@trbchemedica.de |
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Contact: Lucia Hopp |
+49 89 461483-29 |
hopp@trbchemedica.de |
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Germany
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NCT03809962
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OSTH-PMCF-DE-2018-01
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Not Provided
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Studies a U.S. FDA-regulated Drug Product: |
No |
Studies a U.S. FDA-regulated Device Product: |
No |
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Not Provided
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TRB Chemedica AG
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TRB Chemedica AG
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Not Provided
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Principal Investigator: |
Knut Behle, Dr. med. |
OrthopädieZentrum Maschen |
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TRB Chemedica AG
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May 2021
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