Coxarthrosis
Conditions
Brief summary
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.
Interventions
DEVICEOstenil® Plus
Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation
Sponsors
TRB Chemedica AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects ≥ 18 years of age and in good general health condition 2. Signed informed consent 3. Existing Ostenil® Plus recommendation for the treatment of coxarthrosis
Exclusion criteria
1. Known hypersensitivity to one of the OSTENIL® PLUS components 2. Known pregnancy or lactating females 3. Previous/concomitant participation in clinical investigation within the last 3 months prior to study inclusion 4. 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 5. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline | 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 | 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 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 equals the most pain) |
| Change of Range of Motion compared to Baseline (Goniometer measurement) | 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) | 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 | Up to Day 252 after the last injection | — |
| Change of Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline | 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 Quality of Life (HOOS Questionnaire) compared to Baseline | 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 |
Countries
Germany
Outcome results
None listed