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

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ClinicalTrials.gov Identifier: NCT03809962
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Coxarthrosis Device: Ostenil® Plus

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change of Pain Intensity compared to Baseline (VAS-slider) [ Time Frame: 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)

  2. Change of Range of Motion compared to Baseline (Goniometer measurement) [ Time Frame: 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.

  3. Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5) [ Time Frame: 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).

  4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to Day 252 after the last injection ]
  5. Change of Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline [ Time Frame: 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

  6. Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline [ Time Frame: 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

  7. Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline [ Time Frame: 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

  8. Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809962


Contacts
Contact: Raphaela Geiger +49 89 461483-27 geiger@trbchemedica.de
Contact: Lucia Kolbeck +49 89 461483-29 kolbeck@trbchemedica.de

Locations
Germany
OrthopädieZentrum Maschen Recruiting
Seevetal, Germany, 21220
Contact: Knut Behle, Dr. med.         
Principal Investigator: Knut Behle, Dr. med.         
Sponsors and Collaborators
TRB Chemedica AG
Investigators
Principal Investigator: Knut Behle, Dr. med. OrthopädieZentrum Maschen

Responsible Party: TRB Chemedica AG
ClinicalTrials.gov Identifier: NCT03809962     History of Changes
Other Study ID Numbers: OSTH-PMCF-DE-2018-01
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents