Routine Application of Ostenil® in Patients With Gonarthrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TRB Chemedica AG
- Enrollment
- 250
- Locations
- 6
- Primary Endpoint
- Change of Pain Intensity compared to Baseline (VAS-slider)
Study Overview
Brief Summary
PMCF study to observe the routine application of Ostenil® in the treatment of pain and restricted mobility in degenerative and traumatic changes of the knee joint.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects ≥ 18 years of age and in good general health condition
- •Signed informed consent
- •Existing Ostenil® recommendation for the treatment of gonarthrosis
Exclusion Criteria
- •Known hypersensitivity to one of the Ostenil® components
- •Presence of articular effusion in study-relevant knee joint
- •Known pregnancy or lactating females
- •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)
Outcomes
Primary Outcomes
Change of Pain Intensity compared to Baseline (VAS-slider)
Time Frame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252
Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. 10 cm equals the worst pain.
Change of Subjective Therapy Evaluation (KOOS Questionnaire) compared to Baseline
Time Frame: Day 84, Day 168
Knee injury and Osteoarthritis Outcome Score (KOOS) to assess Stiffness, Pain, Function (daily living) and Quality of Life on a 5-point Likert scale.
Incidence of Treatment-Emergent Adverse Events
Time Frame: Up to Day 252
Change of Range of Motion compared to Baseline (Goniometer measurement)
Time Frame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168
Assessment of the Range of Extension and Flexion of the Knee 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 21, Day 28, Day 84, Day 168, Day 252
The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse).
Secondary Outcomes
No secondary outcomes reported