Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577521
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2020-09-22
Brief Title:
The Safety and Efficacy of Single IA-HA Injection in Patients With Knee Osteoarthritis A Prospective Study
Sponsor:
Goztepe Training and Research Hospital
Organization:
Goztepe Training and Research Hospital
Study Overview
Official Title:
Prospective Single Centre Open Label Investigator Initiated Clinical Study to Evaluate the Efficacy and Safety of Cross-linked Intra-Articular Hyaluronic Acid HABiovisc Ortho Single in Patients With Knee Osteoarthritis OA
Status:
COMPLETED
Status Verified Date:
2020-10
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:
This prospective study was planned to carried out among the patients with grade II and III Kellgren Lawrence classification osteoarthritis of the knee attending outpatients clinic to evaluate the effectiveness and safety of viscosupplementation with intra-articular hyaluronic acid injection
Detailed Description:
The study was designed as prospective single-center single-arm open-label observational study The patients with grade II and III Kellgren Lawrence classification osteoarthritis of the knee attending outpatients were planned to enroll the study Patients between the age 18-80 years who did not achieve remission of pain despite receiving the first-line treatment for gonarthrosis including nonsteroidal anti-inflammatory drugs medication activity modification and ice were planned to included in the study A single dose of HA will be injected into the target knee joint Clinical evaluation will be done using the Western Ontario and McMaster Universities Arthritis Index WOMAC and the short form-36 questionnaires SF-36 v2 at baseline 3 months and 6 months by a clinical secretariat
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