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

Active, not recruiting

• Conditions: Coxarthrosis
• Interventions: Device: Ostenil® Plus

• Registration Number: NCT03809962
• Lead Sponsor: TRB Chemedica AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Start: 2019-02-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

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

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ostenil® Plus	Ostenil® Plus	1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval.

Primary Outcome Measures

Name	Time	Method
Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse).
Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline	Day 84 after last injection, Day 168 after last injection	Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Stiffness on a 5-point Likert scale
Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline	Day 84 after last injection, Day 168 after last injection	Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Quality of Life on a 5-point Likert scale
Change of Pain Intensity compared to Baseline (VAS-slider)	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider (10 cm equals the most pain)
Change of Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline	Day 84 after last injection, Day 168 after last injection	Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Pain on a 5-point Likert scale
Change of Range of Motion compared to Baseline (Goniometer measurement)	Day 7, Day 14, Day 84 after last injection, Day 168 after last injection	Assessment of the Range of internal and exernal rotation of the Hip Joint using a Goniometer.
Incidence of Treatment-Emergent Adverse Events	Up to Day 252 after the last injection
Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline	Day 84 after last injection, Day 168 after last injection	Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Function in daily living on a 5-point Likert scale

Trial Locations

Locations (7)

Gemeinschaftspraxis für Orthopädie und Unfallchirurgie; 🇩🇪 Bad Oldesloe, Schleswig-Holstein, Germany

Orthopraxis Kiel; 🇩🇪 Gettorf, Schleswig-Holstein, Germany

Zentrum für Medizin des Bewegungsapparates; 🇩🇪 Heide, Schleswig-Holstein, Germany

Orthopädische Praxis Rahlstedt; 🇩🇪 Hamburg, Germany

Orthopädie Praxis; 🇩🇪 Ramelsloh, Germany

OrthopädieZentrum Maschen; 🇩🇪 Seevetal, Germany

Orthopädische Gemeinschaftspraxis Eutin; 🇩🇪 Eutin, Germany