Clinical trial NCT06141018: Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis (SEM-ART1)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
hyaluronic acid
intraarticular injection
viscosupplementation
Lead sponsor: Semikal Technology
Sponsor class: INDUSTRY
Collaborators: name: Antalya Training and Research Hospital
First posted: 2023-11-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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:

-

Primary outcomes:
measure: Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary outcomes:
measure: Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function score
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Changes in knee functions
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Changes in knee flexor muscle strength
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Changes in knee extensor muscle strength
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Changes in knee functions during 5 times sit to stand test
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Changes in knee functions by 6MWT (6 Minute Walking Test)
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Change in the need for analgesic drug from pre-treatment to post-treatment
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Change in quality of life
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Change in knee pain during movement and rest
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Local reactions in the injection site
timeFrame: 7-10 days post-injection
measure: Adverse events throughout the entire study period
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Semikal Technology
name: Aslıhan Kara
role: STUDY_DIRECTOR
References: