An Observational, Prospective Study of Patients With Chondral and/or Osteochondral Defects of the Knee Treated With NAMIC

Launched by JORDI VILLALBA MODOL · Aug 9, 2018

Keywords

ClinConnect Summary

Background: The treatment of chondral lesions remains a challenge for orthopaedic surgeons. They are most common in young active individuals and result in substantial impairment of quality of life. The conventional joint treatment methods available to date, such as Pridie-type perforations, microfractures using open or arthroscopic approaches and mosaicoplasty are far from satisfactory. Cell-based therapies have also been tested in more advanced research centres.

Nanofractured autologous matrix-induced chondrogenesis (NAMIC) is a simple, easily reproducible implantation technique that can ...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with Outerbridge grade III or IV cartilage lesions localized in the medial or lateral condyle of the knee (Chondral lesions were diagnosed by magnetic resonance T2 mapping and graded according to the Outerbridge classification.).
• • 2. Size of lesion between 1.5 cm2 and 6 cm2 (specify size, alignment, and telemetry)
• • 3. Body mass index ≤ 30 kg/m2.
• • 4. Age 18 to 50.
• • 5. Stable or stabilized knee, with normal axis (\<+/-5º)
• • 6. The patients included in the study will accept to follow the recommended physiotherapy programme, including exercises to be performed at home.
• Exclusion Criteria:
• • 1. Any disease that, in the opinion of the investigator, may prevent the patient from completing the study or interfere with the assessment of the efficacy or security of the treatment proposed.
• • 2. Patients with any disorder of coagulation of the blood or receiving anticoagulant therapy.
• • 3. Patients with rheumatoid arthritis, bi- or tri-compartmental arthritis such as chondrocalcinosis and gout.
• • 4. Malalignment of affected leg with valgus or varus \> 5º (and/or \> vs. contralateral leg)
• • 5. Chondral lesion of the tibial plateau (mirror lesions).
• • 6. Known allergy to metal (nitinol or stainless steel) and/or pork products.
• • 7. Any general pathology that may not allow long-term data collection.