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NCT Number: NCT06141018

Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis (SEM-ART1)

The goal of this clinical trial is to evaluate the effectiveness and safety of intra-articular injection of a cross-linked sodium hyaluronate; SEMICAL GEL-B CROSS, in knee osteoarthritis.

Primary objectives: The aim of this study is to obtain short- and long-term clinical data on the performance and safety of intra-articular injection of SEMICAL GEL B-CROSS, produced and marketed by Semical Biosurgery incorporated company, in knee osteoarthritis patients.

It is also aimed to monitoring known adverse events and complications, detecting previously unknown adverse events and complications, to identify and analyze emerging risks based on real-life data. Participants will receive intra-articular injection of either a cross-linked sodium hyaluronate (SEMICAL GEL-B CROSS); or placebo (isotonic saline solution) at baseline, and will be followed-up for one year to compare the effectiveness and safety of the given therapy.

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This study is active but is not currently recruiting participants.

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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

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

About this study

The study is a randomized controlled, double-blind, two-armed, single-center and cross-over study. After a maximum screening period of 28 days, patients with Kellgren & Lawrence Stage II and III knee osteoarthritis will be randomly assigned to one of the two treatment arms on the day of injection, which is considered Day 0. These treatment arms are:

Group 1: Treatment Arm - Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid)

Group 2: Control Arm - Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) A safety visit will be made 7-10 days after administration of the treatment injection and the injection site will be visually evaluated for local reactions. In addition, an inquiry for injection-related adverse events will also be conducted.

Treatment responses of patients in both groups will be evaluated by a separate researcher blinded to study treatment with predefined objective response criteria.

At the 3rd month visit, the patients in both groups will be crossed-over and those who received a placebo at baseline will receive a hyaluronic acid injection at the 3rd month, while those who receive a hyaluronic acid injection at baseline will receive a placebo at the 3rd month. Efficacy evaluations will continue to be made at every three months for one year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 and over, both male and female
  • Diagnosed with clinical knee osteoarthritis according to the American College of
  • Rheumatology (ACR) criteria, with Kellgren & Lawrence stage II and III osteoarthritic findings on antero-posterior knee radiographs
  • Able to provide written informed consent

Exclusion criteria

-

Treatment and study plan

Cross-linked intra-articular hyaluronic acid

Device

Patients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month.

Placebo

Other

Patients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month.

Other names: 3 ml isotonic saline solution

Primary outcomes

  1. Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    The alteration in pain arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.

Secondary outcomes

  1. Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function score

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    The alteration in pain arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.

  2. Changes in knee functions

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    The alteration in function arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.

  3. Changes in knee flexor muscle strength

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    Knee flexor muscle strength assessed by myometer

  4. Changes in knee extensor muscle strength

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    Knee extensor muscle strength assessed by myometer

  5. Changes in knee functions during 5 times sit to stand test

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    5 times sit to stand test

  6. Changes in knee functions by 6MWT (6 Minute Walking Test)

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    6 minute walking test

  7. Change in the need for analgesic drug from pre-treatment to post-treatment

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    Will be assessed by patient diary

  8. Change in quality of life

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    Will be assessed by 36-item Short Form Survey

  9. Change in knee pain during movement and rest

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    Will be assessed by Visual Analogue Scale 1-10 (1: no pain, 10: very much pain)

  10. Local reactions in the injection site

    Time frame: 7-10 days post-injection

    A safety visit will be performed 7-10 days after administration of the treatment injection and the injection site will be visually assessed for local reactions.

  11. Adverse events throughout the entire study period

    Time frame: Through study completion, an average of 1 year.

    Adverse events will be questioned throughout the entire study period

Sponsors and collaborators

Lead sponsor

Semikal Technology

Industry

Collaborators

  • Antalya Training and Research Hospital

Registry information

Official study title

Safety and Effectiveness of Intra-articular Injection of a Cross-linked Sodium Hyaluronate in Knee Osteoarthritis: A Randomized, Prospective, Double-blind, Placebo-controlled, Cross-over, Post-marketing Clinical Follow-up Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2023
Registry last updated
Aug 21, 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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