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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06141018
• Other study ID #: SEM-ART1
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: November 2023
• Source: Semikal Technology
• Contact: Aslihan Kara
• Phone: 0090242 2494287
• Email: info[@]semikal.com.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: May 31, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

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.

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital	Antalya

Sponsors (2)

Lead Sponsor	Collaborator
Semikal Technology	Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function score	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	Changes in knee functions	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.	Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary	Changes in knee flexor muscle strength	Knee flexor muscle strength assessed by myometer	Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary	Changes in knee extensor muscle strength	Knee extensor muscle strength assessed by myometer	Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary	Changes in knee functions during 5 times sit to stand test	5 times sit to stand test	Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary	Changes in knee functions by 6MWT (6 Minute Walking Test)	6 minute walking test	Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary	Change in the need for analgesic drug from pre-treatment to post-treatment	Will be assessed by patient diary	Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary	Change in quality of life	Will be assessed by 36-item Short Form Survey	Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary	Change in knee pain during movement and rest	Will be assessed by Visual Analogue Scale 1-10 (1: no pain, 10: very much pain)	Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary	Local reactions in the injection site	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.	7-10 days post-injection
Secondary	Adverse events throughout the entire study period	Adverse events will be questioned throughout the entire study period	Through study completion, an average of 1 year.