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

NCT05348525 | Unknown

• 1 other identifier: YYDATP-PMCF-TR
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• KOOS for Pain at 12 weeks

  • Functional assessment of HYALEXO® by KOOS (Knee Injury and Osteoarthritis Outcome score) for Pain subscale at 12 weeks after the last administration of the investigational product, compared to the baseline. This was the endpoint used for the sample size calculation.

  12 weeks

Secondary Outcomes (6)

• KOOS for Symptoms, Activity of Daily Living, Sport and Recreation and knee related Quality of life

  1,6,12 weeks and 6 months

• KOOS for Pain at 1, 6 weeks and 6 months

  1, 6 weeks and 6 months

• Weight-bearing pain using a Visual Analogue Scale(VAS)

  1,6,12 weeks and 6 months

• Changes is rest pain(VAS)

  1,6,12 weeks and 6 months

• Changes in motion pain(VAS)

  1,6,12 weeks and 6 months

Other Outcomes (2)

• Secondary Safety endpoints

  baseline(day0), all follow up visit(day7,14,21,56,98)

• Secondary Safety endpoints

  all visit(screening, baseline, day7,14,21,56,98,194)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the two Turkish primary care clinics

You may qualify if:

• Patients older than 18 years old(inlcusive≥18years).
• Men or women.
• Patients suffering from painful chronic idiopathic symptomatic degenerative joint diseases(clinical evidence) OR knee osteoarthritis (as defined by the American College of Rheumatology (ACR) criteria); for patients with osteoarthritis at both knees, only the most painful one will be included in the study.
• VAS knee pain≥40mm at screening and 30 days before.
• Patients willing and able to comply with study terms.
• Patients willing to discontinue all other degenerative joint diseases or knee osteoarthritis treatments.

You may not qualify if:

• Patients that are unable or unwilling to provide informed consent and/or patients participating in a concurrent clinical trial and/or patients that have participated in a similar clinical trial within the last 30 days.
• Patients with known hypersensitivity to any components of investigational product.
• Patients with infected or severely inflamed joints
• Patients with skin diseases or infections in the area of the injection site.
• Patients with hepatic failure or history thereof.

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yüksel Ersoy, Dr

  İnönü University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Serpil Tuna, Dr

  AKDENİZ University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Barattini, MD

CONTACT

+39 335 5437574; franco.barattini@tigermedgrp.com

Ioana Gâlcă, CPM

CONTACT

+40 741 107 508; ioana.galca@tigermedgrp.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 27, 2022
• Study Start: July 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-04