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

NCT ID: NCT06141018

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2026-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cross-linked intra-articular hyaluronic acid

Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid)

Group Type: ACTIVE_COMPARATOR

Cross-linked intra-articular hyaluronic acid

Intervention Type: 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

Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) at the same dose as the treatment arm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Cross-linked intra-articular hyaluronic acid

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.

Intervention Type: DEVICE

Placebo

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.

Intervention Type: OTHER

Other Intervention Names

3 ml isotonic saline solution

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Semikal Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aslıhan Kara

Role: STUDY_DIRECTOR

Semikal Technology

Locations

Antalya Training and Research Hospital

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SEM-ART1

Identifier Type: -

Identifier Source: org_study_id