Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05322005
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-15
First Post:
2022-03-11
Brief Title:
Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy with Injection of Polynucleotides
Sponsor:
Mastelli Srl
Organization:
Mastelli Srl
Study Overview
Official Title:
A Non-randomized Multicentre Study for the Evaluation of the Clinical Performance and Safety of the Augmentation-to-surgery and Conservative Treatments for the Degenerative Meniscopathy with Injection of Polynucleotide Gel
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 is a non-randomized multicentre study for the evaluation of the clinical performance and safaty of the augmentation-to-surgery and conservative treatments for the degenerative meniscopathies with injection of polynucleotide gel
Detailed Description:
Meniscal tear plays a significant role among the multitude of ethiologies of knee pain In the setting of chronic meniscus degeneration healing potential remains low due to a vascular penetration of less than one-third of the adult meniscus Currently both conservative and surgical modalities can be utilized in the treatment of the painful degenerative menisci and no gold standard treatment has been identified Polynucleotide gel Condrotide is a polynucleotide solution used in case of degenerative painful join pathologies favouring the physiological mechanism of joint repair because of the capacity to normalize the viscosity of synovial fluid and supposed to improve the joint trophism The present study aims at evaluating the capacity of the polynucleotide gel injection to stimulate healing and slow down progression of meniscal degeneration through augmentation-to-surgery and conservative treatments for the degenerative meniscopathies
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