Routine Application of Ostenil® in Patients with Gonarthrosis

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 Overview

• Status: Completed
• Conditions: Gonarthrosis
• Intervention / Treatment: Device: Ostenil®

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81825
      • Orthopädisches Versorgungszentrum München-Ost
    • München, Bavaria, Germany, 80331
      • Orthopädie München
  • Bayern
    • München, Bayern, Germany, 80331
      • Orthopädie am Altheimer Eck
    • München, Bayern, Germany, 80331
      • Orthopädische Praxis am Isartor
    • München, Bayern, Germany, 80797
      • MVZ am Nordbad
    • München, Bayern, Germany, 80993
      • Orthopädische Praxis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 with Gonarthrosis and a Recommendation for Treatment with Ostenil®.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ostenil®; 3-5 injections of sodium hyaluronate 1 % (20 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.	Device: Ostenil®; Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation.

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 worst pain.	Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252
Change of Range of Motion compared to Baseline (Goniometer measurement)	Assessment of the Range of Extension and Flexion of the Knee Joint using a Goniometer.	Day 7, Day 14, Day 21, Day 28, Day 84, Day 168
Change of Subjective Therapy Evaluation (KOOS Questionnaire) compared to Baseline	Knee injury and Osteoarthritis Outcome Score (KOOS) to assess Stiffness, Pain, Function (daily living) and Quality of Life on a 5-point Likert scale.	Day 84, Day 168
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 21, Day 28, Day 84, Day 168, Day 252
Incidence of Treatment-Emergent Adverse Events		Up to Day 252

Collaborators and Investigators

• Sponsor: TRB Chemedica AG
• Investigators: Principal Investigator: Michael Krüger-Franke, Dr. med., MVZ am Nordbad

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OSTK-PMCF-DE-2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No