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

Study Overview
=================
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.

Official Title
-----------------
Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis

Conditions
-----------------
Coxarthrosis

Intervention / Treatment
-----------------
* Device: Ostenil® Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ostenil® Plus<br>1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval. | Device: Ostenil® Plus<br>* Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain Intensity compared to Baseline (VAS-slider) | Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider (10 cm equals the most pain) | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | 
| Change of Range of Motion compared to Baseline (Goniometer measurement) | Assessment of the Range of internal and exernal rotation of the Hip Joint using a Goniometer. | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | 
| Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5) | The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse). | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | 
| 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 | Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Pain on a 5-point Likert scale | Day 84 after last injection, Day 168 after last injection | 
| Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline | Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Stiffness on a 5-point Likert scale | Day 84 after last injection, Day 168 after last injection | 
| Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline | Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Function in daily living on a 5-point Likert scale | Day 84 after last injection, Day 168 after last injection | 
| Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline | Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Quality of Life on a 5-point Likert scale | Day 84 after last injection, Day 168 after last injection |