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Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of ORTHIX PLUS

NCT05348525 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2022-04-27

No results posted yet for this study

Summary

This trial is a post marketing clinical follow up study, aiming to evaluate the performance and safety of ORTHIX PLUS for pain relief in patients suffering from osteoarthritis or degenerative joint diseases.

The study will involve 54 subjects, who will be enrolled in 2 centers in Turkey. The primary objective is to evaluate the overall performance of ORTHIX PLUS in providing relief in patients suffering from painful knee ostearthritis or degenerative joint diseases when used according to indications for use.

The first secondary objective is to evaluate the overall performance of ORTHIX PLUS in providing relief when used according to indications for use, at different time points. The other secondary objective is to evaluate the overall safety during the study period.

Conditions

  • Osteoarthritis, Knee
  • Degenerative Joint Disease of Knee

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Yooyoung Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yüksel Ersoy, Dr · İnönü University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  • Serpil Tuna, Dr · AKDENİZ University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2022-09-30
Completion
2023-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05348525 on ClinicalTrials.gov