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

NCT03625180 | Unknown FDA Drug

• 1 other identifier: 2017584
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chondral Defect; Osteochondral Defect

Keywords

nanofractured autologous matrix-induced chondrogenesis

Outcome Measures

Primary Outcomes (1)

• Amount of tissue repaired

  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.

  12 months

Secondary Outcomes (7)

• Localisation of the lesion

  preoperative, and at 12 months

• Size of the lesion

  preoperative, and at 12 months

• Mechanical alignment

  preoperative, and at 12 months

• Surgeries of cartilage or that may directly or indirectly affect cartilage

  12 months

• Pain in the knee: Visual Analogue Scale

  preoperative, and at 12 months

Study Arms (1)

Treatment

NAMIC technique

Biological: NAMIC: nanofractured autologous matrix-induced chondrogenesis

Interventions

NAMIC: nanofractured autologous matrix-induced chondrogenesis BIOLOGICAL

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).

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Outerbridge grade III or IV cartilage lesions localized in the medial or lateral condyle of the knee.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordi Villalba Modol: lead

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 10, 2018
• Study Start: July 18, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

ES (1)