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Completed

NCT Number: NCT07096050

Post Marketing Clinical Follow up Study of HyaleXo

Hyaluronic acid is a polysaccharide naturally present in several human tissues such as cartilage. It is the major constituent of synovial fluid and provides its viscosity and elasticity. In traumatic and degenerative joint diseases, the amount of hyaluronic acid is reduced. The consequent loss of viscosity by the synovial fluid may be the cause of painful symptoms. HyaleXo action, according to its composition (sodium hyaluronate of very high molecular weight), may restore the viscoelastic properties of synovial fluid, attenuate pain and improve the mobility of the joint. These characteristics allow HyaleXo to be used for the symptomatic relief of pain in patients suffering from osteoarthritis (OA) or degenerative joint diseases causing an alteration of the functionality of the synovial fluid.

The patient will be treated with HyaleXo as reported in the Instruction for use (IFU) of the device: via injection once a week for 3 weeks using standard technique. The patient pain management strategy should be according to the standard clinical practices and remains at the discretion of the investigator.

The Research Question of the present study is the following: in a population of men and women suffering from painful knee osteoarthritis or degenerative joint disease will very high molecular weight fraction of sodium Hyaluronate (HyaleXo) significantly decrease and / or relieve the pain after 1,6,12 weeks and 6 months of the third injection?

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Echipa Medical 33

Timișoara, 30, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years old (inclusive ≥ 18 years).
  • 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 OA at both knees, only the most painful one will be included in the study.
  • VAS knee pain ≥ 40 mm at screening and 30 days before.
  • Patients willing and able to comply with study terms.
  • Patients willing to discontinue all other OA treatments

Exclusion criteria

  • Patients that are unable or unwilling to provide informed consent, and/or patients participating in a concurrent clinical trial and/or patients who have participated in a similar clinical trial within the last days.
  • Patients with known hypersensitivity to any components of investigational product.
  • Patients who are pregnant or breastfeeding. 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.

Treatment and study plan

HyaleXo

Other

Treatment of HyaleXo 3 times

Primary outcomes

  1. Functional assessment of HyaleXo by KOOS

    Time frame: 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.

Secondary outcomes

  1. Functional assessment of HyaleXo by KOOS

    Time frame: 1,6,12 weeks and 6 months

    Functional Assessment of HyaleXo by KOOS for other Symptoms, Activity of Daily Living (ADL), Sport and Recreation (Sport/Rec) function and knee related Quality of life (QoL) at 1, 6, 12 weeks and 6 months after the last administration of the investigational product, compared to baseline

  2. Functional assessment of HyaleXo by KOOS

    Time frame: 1,6 weeks and 6 months

    Functional Assessment of HyaleXo by KOOS for Pain subscale at 1, 6 weeks and 6 months after the last administration of the investigational product, compared to baseline

  3. Visual Analgoue Sclae

    Time frame: 1,6,12 weeks and 6 months

    • Changes in the weight-bearing pain using a Visual Analogue Scale (100 mm - VAS) at 1, 6, 12 weeks and 6 months after the last administration, compared to the baseline.

  4. Visual Analgoue Sclae

    Time frame: 1,6,12 weeks and 6 months

    • Changes in the rest pain (100 mm - VAS) at 1, 6, 12 weeks and 6 months after the last administration, compared to the baseline.

  5. Visual Analgoue Sclae

    Time frame: 1,6,12 weeks and 6 months

    • Changes in the motion pain (pain after 15 m walk) (100 mm - VAS) at 1, 6, 12 weeks and 6 months after the last administration, compared to the baseline.

  6. Patient Global Pain Assessment

    Time frame: 1,6,12 weeks and 6 months

    • Patient Global Pain Assessment (100 mm - VAS) at 1, 6, 12 weeks and 6 months after the last administration, compared to the baseline.

Sponsors and collaborators

Lead sponsor

Yooyoung Pharmaceutical Co., Ltd.

Industry

Collaborators

  • TigerMed

Registry information

Official study title

Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HyaleXo for Pain Relief in Patients Suffering From Osteoarthritis or Degenerative Joint Diseases

Acronym: PMCF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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