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

Sponsor

Semikal Technology (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06141018

Collaborator

Antalya Training and Research Hospital (Other)

102

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Device: Cross-linked intra-articular hyaluronic acid Other: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Triple-blind

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

May 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cross-linked intra-articular hyaluronic acid Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid)	Device: 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.
Placebo Comparator: Placebo Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) at the same dose as the treatment arm	Other: 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. Other Names: 3 ml isotonic saline solution

Arm

Intervention/Treatment

Active Comparator: Cross-linked intra-articular hyaluronic acid

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

Device: 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.

Placebo Comparator: Placebo

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

Other: Placebo

Other Names:

3 ml isotonic saline solution

Outcome Measures

Primary Outcome Measures

Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores [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 Outcome Measures

Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function score [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.
Changes in knee functions [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.
Changes in knee flexor muscle strength [Baseline, 3 months, 6 months, 9 months, and 12 months.]
Knee flexor muscle strength assessed by myometer
Changes in knee extensor muscle strength [Baseline, 3 months, 6 months, 9 months, and 12 months.]
Knee extensor muscle strength assessed by myometer
Changes in knee functions during 5 times sit to stand test [Baseline, 3 months, 6 months, 9 months, and 12 months.]
5 times sit to stand test
Changes in knee functions by 6MWT (6 Minute Walking Test) [Baseline, 3 months, 6 months, 9 months, and 12 months.]
6 minute walking test
Change in the need for analgesic drug from pre-treatment to post-treatment [Baseline, 3 months, 6 months, 9 months, and 12 months.]
Will be assessed by patient diary
Change in quality of life [Baseline, 3 months, 6 months, 9 months, and 12 months.]
Will be assessed by 36-item Short Form Survey
Change in knee pain during movement and rest [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)
Local reactions in the injection site [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.
Adverse events throughout the entire study period [Through study completion, an average of 1 year.]
Adverse events will be questioned throughout the entire study period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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