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出境医 / 临床实验 / Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis

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

Study Description
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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 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 : August 2024
Estimated Study Completion Date : August 2024
Arms 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

Outcome Measures
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


Eligibility Criteria
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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)
Contacts and Locations

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

Locations
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Germany
Gemeinschaftspraxis für Orthopädie und Unfallchirurgie Recruiting
Bad Oldesloe, Schleswig-Holstein, Germany, 23843
Contact: Sönke Wolters, Dr. med.         
Orthopraxis Kiel Recruiting
Gettorf, Schleswig-Holstein, Germany, 24214
Contact: Christoph Spoo         
Orthopädische Gemeinschaftspraxis Eutin Recruiting
Eutin, Germany, 23701
Contact: Bernd Schulte         
Orthopädische Praxis Rahlstedt Completed
Hamburg, Germany, 22143
Orthopädie Praxis Recruiting
Ramelsloh, Germany, 21220
Contact: Darja Becker, Dr.         
OrthopädieZentrum Maschen Active, not recruiting
Seevetal, Germany, 21220
Sponsors and Collaborators
TRB Chemedica AG
Investigators
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Principal Investigator: Knut Behle, Dr. med. OrthopädieZentrum Maschen
Tracking Information
First Submitted Date January 14, 2019
First Posted Date January 18, 2019
Last Update Posted Date May 28, 2021
Actual Study Start Date January 30, 2019
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2019)
  • 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)
  • 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.
  • 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).
  • 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 [ 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
Official Title Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.
Condition Coxarthrosis
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
Study Groups/Cohorts Ostenil® Plus
1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval.
Intervention: Device: Ostenil® Plus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 9, 2020)
250
Original Estimated Enrollment
 (submitted: January 17, 2019)
50
Estimated Study Completion Date August 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Raphaela Geiger +49 89 461483-27 geiger@trbchemedica.de
Contact: Lucia Hopp +49 89 461483-29 hopp@trbchemedica.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03809962
Other Study ID Numbers OSTH-PMCF-DE-2018-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party TRB Chemedica AG
Study Sponsor TRB Chemedica AG
Collaborators Not Provided
Investigators
Principal Investigator: Knut Behle, Dr. med. OrthopädieZentrum Maschen
PRS Account TRB Chemedica AG
Verification Date May 2021