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

Spain24 participantsStarted 2018-07-18

Plain-language summary

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

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.).
✓. Size of lesion between 1.5 cm2 and 6 cm2 (specify size, alignment, and telemetry)
✓. Body mass index ≤ 30 kg/m2.
✓. Age 18 to 50.
✓. Stable or stabilized knee, with normal axis (\<+/-5º)
✓. The patients included in the study will accept to follow the recommended physiotherapy programme, including exercises to be performed at home.

Exclusion criteria

✕. 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.
✕. Patients with any disorder of coagulation of the blood or receiving anticoagulant therapy.
✕. Patients with rheumatoid arthritis, bi- or tri-compartmental arthritis such as chondrocalcinosis and gout.
✕. Malalignment of affected leg with valgus or varus \> 5º (and/or \> vs. contralateral leg)
✕. Chondral lesion of the tibial plateau (mirror lesions).
✕. Known allergy to metal (nitinol or stainless steel) and/or pork products.
✕. Any general pathology that may not allow long-term data collection.

What they're measuring

Amount of tissue repaired

Timeframe: 12 months

Trial details

NCT IDNCT03625180

SponsorJordi Villalba Modol

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Chondral Defect trials