NCT05322005

Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mastelli S.r.l · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meniscus Tear
• Meniscus Lesion

Interventions

Type	Name	Description
PROCEDURE	partial meniscectomy	Arthroscopic procedure
DEVICE	Condrotide® (polynucleotides gel: class III medical device)	Condrotide® Polynucleotide gel is a joint lubricating and viscosizing agent, given by intraarticular and intra-meniscal injection

Timeline

• Start date: 2020-10-26
• Primary completion: 2024-07-27
• Completion: 2024-07-27
• First posted: 2022-04-11
• Last updated: 2025-08-12

Locations

2 sites across 2 countries: Belgium, Italy