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

NCT06141018 | Active Not Recruiting

• 1 other identifier: SEM-ART1
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; hyaluronic acid; intraarticular injection; viscosupplementation

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, 3 months, 6 months, 9 months, and 12 months.

Secondary Outcomes (11)

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

  Baseline, 3 months, 6 months, 9 months, and 12 months.

• Changes in knee functions

  Baseline, 3 months, 6 months, 9 months, and 12 months.

• Changes in knee flexor muscle strength

  Baseline, 3 months, 6 months, 9 months, and 12 months.

• Changes in knee extensor muscle strength

  Baseline, 3 months, 6 months, 9 months, and 12 months.

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

  Baseline, 3 months, 6 months, 9 months, and 12 months.

Study Arms (2)

Cross-linked intra-articular hyaluronic acid

ACTIVE COMPARATOR

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

Device: Cross-linked intra-articular hyaluronic acid

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

Cross-linked intra-articular hyaluronic acid

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.

Also known as: 3 ml isotonic saline solution

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Semikal Technology: lead
• Antalya Training and Research Hospital: collaborator

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Aslıhan Kara

  Semikal Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 21, 2023
• Study Start: January 15, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)