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NCT03809962 Clinical Trial

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

Coxarthrosis Clinical Trial

Official title:
Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03809962
Other study ID # OSTH-PMCF-DE-2018-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2019
Est. completion date August 2024

Study information
Verified date April 2024
Source TRB Chemedica AG
Contact Raphaela Geiger
Phone +49 89 461483-27
Email geiger@trbchemedica.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Ostenil® Plus
Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation

Locations
Country Name City State
Germany Gemeinschaftspraxis für Orthopädie und Unfallchirurgie Bad Oldesloe Schleswig-Holstein
Germany Orthopädische Gemeinschaftspraxis Eutin Eutin
Germany Orthopraxis Kiel Gettorf Schleswig-Holstein
Germany Orthopädische Praxis Rahlstedt Hamburg
Germany Zentrum für Medizin des Bewegungsapparates Heide Schleswig-Holstein
Germany Orthopädie Praxis Ramelsloh
Germany OrthopädieZentrum Maschen Seevetal

Sponsors (1)
Lead Sponsor Collaborator
TRB Chemedica AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Incidence of Treatment-Emergent Adverse Events Up to Day 252 after the last injection
Primary 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
Primary 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
Primary 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
Primary 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
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Active, not recruiting NCT00722982 - Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty N/A
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Active, not recruiting NCT01578746 - Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty Phase 4
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