An Observational, Prospective Study of Patients With Chondral and/or Osteochondral Defects of the Knee Treated With NAMIC (KNAMIC)
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|ClinicalTrials.gov Identifier: NCT03625180|
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
It is a prospective observational study of hospital cases. The objective is to determine the decrease of lesion size and the regeneration of chondral tissue in femoral condyle cartilage defect treated with NAMIC.
24 patients will be included
|Condition or disease||Intervention/treatment|
|Chondral Defect Osteochondral Defect||Biological: NAMIC: nanofractured autologous matrix-induced chondrogenesis|
|Study Type :||Observational|
|Estimated Enrollment :||24 participants|
|Official Title:||An Observational, Prospective, Multicentre Study of Patients With Outerbridge Grade III / IV Chondral and/or Osteochondral Defects of the Knee Treated With Nanofractured Autologous Matrix-induced Chondrogenesis|
|Actual Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Biological: NAMIC: nanofractured autologous matrix-induced chondrogenesis
the NAMIC technique consists in: debridement of damaged tissue, removal of calcified cartilage with retention of healthy surrounding vertical cartilage, minimally invasive subchondral bone marrow stimulation, nanofracture (Nano FX, Arthrosurface, USA), and a posteriori protect the lesion, stabilization of the clot, and facilitate stem cell adhesion and proliferation that migrate from the bone marrow with a type I/ III collagen and elastine membrane (Cartimaix, Matricel, Germany).
- Amount of tissue repaired [ Time Frame: 12 months ]Amount of tissue repaired, calculating the filling area of the lesion. Magnetic resonance will be used to determine the filling area at 12-month outpatient follow-up visit.
- Localisation of the lesion [ Time Frame: preoperative, and at 12 months ]THe localisation of the lesion will be described, using magnetic resonance.
- Size of the lesion [ Time Frame: preoperative, and at 12 months ]Magnetic resonance will be used to determine the size of the lesion, measured in mm.
- Mechanical alignment [ Time Frame: preoperative, and at 12 months ]Limb alignment (anatomic relation of bone axes) determined by telemetry. Measured in degrees.
- Surgeries of cartilage or that may directly or indirectly affect cartilage [ Time Frame: 12 months ]Surgeries of cartilage or that may directly or indirectly affect cartilage such as meniscectomy, osteotomy, microfracture, mosaicoplasty or ligament repair
- Pain in the knee: Visual Analogue Scale [ Time Frame: preoperative, and at 12 months ]Pain measured with a Visual Analogue Scale (VAS), which is a self-reported, single question, 11 point scale (from 0 no pain, to 10 unbearable pain).
- KOOS score [ Time Frame: preoperative, and at 12 months ]KOOS (Knee injury and Osteoarthritis Outcome Score) is a self-reported measure including 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS subscale scores will be aggregated and averaged as the primary outcome.
- Activity level: Tegner Activity Scale [ Time Frame: preoperative, and at 12 months ]Patient's activity level measured with the Tegner Activity Scale (TAS). It is a self-reported measure including 11 levels of activity (from 0 to 10) measuring work and sport activities graded numerically.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625180
|Corporació Sanitària Parc Taulí||Recruiting|
|Sabadell, Barcelona, Spain, 08208|
|Contact: Jordi Villalba-Modol, MD +34937231010 email@example.com|
|Principal Investigator: Jordi Villalba-Modol, MD|