Routine Application of Ostenil® in Patients With Gonarthrosis

Completed

• Conditions: Gonarthrosis
• Interventions: Device: Ostenil®

• Registration Number: NCT03734315
• Lead Sponsor: TRB Chemedica AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Study Start: 2019-01-08
• Primary Completion: 2023-01-12
• Study Completion: 2023-01-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ostenil®	Ostenil®	3-5 injections of sodium hyaluronate 1 % (20 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.

Primary Outcome Measures

Name	Time	Method
Change of Pain Intensity compared to Baseline (VAS-slider)	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	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	Up to Day 252
Change of Range of Motion compared to Baseline (Goniometer measurement)	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)	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).

Trial Locations

Locations (6)

Orthopädie am Altheimer Eck; 🇩🇪 München, Bayern, Germany

Orthopädische Praxis; 🇩🇪 München, Bayern, Germany

Orthopädisches Versorgungszentrum München-Ost; 🇩🇪 Munich, Bavaria, Germany

Orthopädie München; 🇩🇪 München, Bavaria, Germany

Orthopädische Praxis am Isartor; 🇩🇪 München, Bayern, Germany

MVZ am Nordbad; 🇩🇪 München, Bayern, Germany