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

TRB Chemedica AG170 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

170

Conditions

Coxarthrosis

Interventions

Ostenil® PlusDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Locations (7)

Orthopädische Praxis Rahlstedt

Hamburg, Free and Hanseatic City of Hamburg, Germany

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

Outcomes

Primary Outcomes

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)

Time frame: 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.

Time frame: 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).

Time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection

Incidence of Treatment-Emergent Adverse Events

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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