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

NCT05322005 | Completed DMC

• 1 other identifier: DDM22M
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Meniscus Tear; Meniscus Lesion

Outcome Measures

Primary Outcomes (1)

• Overall Knee Injury Osteoarthritis Outcome Score (KOOS) will be measured

  The change of overall KOOS score will be evaluated from baseline (V1) to 6 (V6), 12 (V7), and 24 (V8) months after treatment completion. An improvement of 10 points in the score will be considered success. The KOOS score assesses; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

  24 months (end of follow up)

Secondary Outcomes (4)

• The change of the radiological assessment of the cartilage by a 5-points Likert scale

  24 months

• The change of the International Knee Documentation Committee (IKDC Questionnaire)

  24 months

• The change of the Tegner activity score from baseline (V1) to 3 (V5), 6 (V6), 12 (V7), 24 (V8) months after treatment completion (T0).

  24 months

• AE and device deficiencies Reporting

  24 months

Study Arms (2)

Arm A: augmentation to surgery

EXPERIMENTAL

Patients will be surgically treated with partial meniscectomy combined with an intraarticular and intra-meniscal injection of polynucleotide gel, during an arthroscopic procedure. After 6 weeks the patients attend a second injection session, during an ambulatorial visit. At 8 weeks from the surgery the patients attend the third ambulatorial injection session

Procedure: partial meniscectomy; Device: Condrotide® (polynucleotides gel: class III medical device)

Arm B: conservative treatment

EXPERIMENTAL

The patients are going to receive three injections session (polynucleotide gel) performed with a time interval of 2 weeks.

Device: Condrotide® (polynucleotides gel: class III medical device)

Interventions

partial meniscectomy PROCEDURE

Arthroscopic procedure

Arm A: augmentation to surgery

Condrotide® (polynucleotides gel: class III medical device) DEVICE

Condrotide® Polynucleotide gel is a joint lubricating and viscosizing agent, given by intraarticular and intra-meniscal injection

Arm A: augmentation to surgery; Arm B: conservative treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects with age between 18 and 65 years
• Presence of symptomatic degenerative meniscus tear
• Presence of one of the following unilateral symptoms: pain, catching, or locking of the knee
• Non responsive to physical therapy for at least 3-4 weeks
• Be in neutral alignment +/- 5 degrees of the mechanical axis
• Subject must be physically and mentally willing and able to comply with the study follow-up schedule
• Subject must sign Ethic committe approved informed consent
• Subject is willing and able to comply with all study procedures, including visits and diagnostic procedures

You may not qualify if:

• Radiographic osteoarthritis of the knee in any compartment greater than Kellgren-Lawrence (KL) grade 3.
• Presence of bone marrow edema (BME) at the index knee.
• Presence of knee instability.
• Have a varus or valgus knee deformity \> 5 degrees.
• Have meniscal roots tears.
• Have discoid meniscus.
• Have patella instability or non-anatomically positioned patella.
• Have a knee flexion contracture \> 10 degrees.
• Be unable to flex the knee to 90 degrees.
• Have a leg length discrepancy causing a noticeable limp.
• Have an active infection or tumor.
• Have any type of knee joint inflammatory disease including Sjogren's syndrome.
• Have neuropathic knee osteoarthropathy, also known as Charcot joint.
• Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric or cognitive conditions.
• Participation to another clinical trial or clinical investigation in the previous 3 months.

Sponsors & Collaborators

• Mastelli S.r.l: lead

Study Sites (2)

Peter Verdonk

Deurne, 2100, Belgium

Location

Elizaveta Kon

Milan, Milan, 20089, Italy

Location

Study Officials

• Elizaveta Kon, Prof.

  Plastic surgery IRCCS Humanitas

  PRINCIPAL INVESTIGATOR

• Peter Verdonk, Prof.

  Monica Ziekenhuizen Antwerpen en Deurne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment A (augmentation-to-surgery): subjects surgically treated with partial meniscectomy combined with an intraarticular and intra-meniscal injection of polynucleotide gel. Treatment B (conservative): subjects treated with three injections session of polynucleotide gel.

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 11, 2022
• Study Start: October 26, 2020
• Primary Completion: July 27, 2024
• Study Completion: July 27, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

BE (1); IT (1)