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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Arm B: conservative treatment | Experimental | The patients are going to receive three injections session (polynucleotide gel) performed with a time interval of 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| partial meniscectomy | Procedure | Arthroscopic procedure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the radiological assessment of the cartilage by a 5-points Likert scale | Likert scale scoring: 0=worsened; 1= not worsened or improved; 2= slightly improved; 3= improved; 4= very much improved). The articular cartilage and meniscal appearance change will be evaluated from baseline (V1) to 6 (V6), 12 (V7), 24 (V8) months after treatment completion (T0). | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizaveta Kon, Prof. | Plastic surgery IRCCS Humanitas | Principal Investigator |
| Peter Verdonk, Prof. | Monica Ziekenhuizen Antwerpen en Deurne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Verdonk | Deurne | 2100 | Belgium | |||
| Elizaveta Kon |
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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.
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| 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 |
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| The change of the International Knee Documentation Committee (IKDC Questionnaire) | Is a knee-specific patient-reported outcome measure. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function. | 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). | The Tegner activity scale is a one-item score evaluating work and sports activities on a scale of 0 to 10. Zero represents disability. | 24 months |
| AE and device deficiencies Reporting | Will be evaluated:
| 24 months |
| Milan |
| Milan |
| 20089 |
| Italy |