Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-10-25
Brief Title:
Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis SEM-ART1
Sponsor:
Semikal Technology
Organization:
Semikal Technology
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 09 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
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 09 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None