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

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.

Study Overview

• Status: Completed
• Conditions: Coxarthrosis
• Intervention / Treatment: Device: Ostenil® Plus

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• Germany
  • Eutin, Germany, 23701
    • Orthopädische Gemeinschaftspraxis Eutin
  • Hamburg, Germany, 22143
    • Orthopädische Praxis Rahlstedt
  • Ramelsloh, Germany, 21220
    • Orthopädie Praxis
  • Seevetal, Germany, 21220
    • OrthopädieZentrum Maschen
  • Schleswig-Holstein
    • Bad Oldesloe, Schleswig-Holstein, Germany, 23843
      • Gemeinschaftspraxis für Orthopädie und Unfallchirurgie
    • Gettorf, Schleswig-Holstein, Germany, 24214
      • Orthopraxis Kiel
    • Heide, Schleswig-Holstein, Germany, 25746
      • Zentrum für Medizin des Bewegungsapparates

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

Adult patients with Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.

Description

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)

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® Plus; 1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval.	Device: Ostenil® Plus; Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % 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 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

Collaborators and Investigators

• Sponsor: TRB Chemedica AG
• Investigators: Principal Investigator: Knut Behle, Dr. med., OrthopädieZentrum Maschen; Principal Investigator: Darja Becker, Dr. med., Orthopädie Praxis Dr. Darja Becker

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Actual): May 14, 2025
• Study Completion (Actual): May 14, 2025

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

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

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