ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03625180
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Jordi Villalba Modol, Corporacion Parc Tauli

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


Condition or disease Intervention/treatment
Chondral Defect Osteochondral Defect Biological: NAMIC: nanofractured autologous matrix-induced chondrogenesis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Treatment
NAMIC technique
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Localisation of the lesion [ Time Frame: preoperative, and at 12 months ]
    THe localisation of the lesion will be described, using magnetic resonance.

  2. 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.

  3. Mechanical alignment [ Time Frame: preoperative, and at 12 months ]
    Limb alignment (anatomic relation of bone axes) determined by telemetry. Measured in degrees.

  4. 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

  5. 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).

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Locations
Spain
Corporació Sanitària Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Jordi Villalba-Modol, MD    +34937231010    jvillalba@tauli.cat   
Principal Investigator: Jordi Villalba-Modol, MD         
Sponsors and Collaborators
Jordi Villalba Modol

Responsible Party: Jordi Villalba Modol, Doctor, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03625180     History of Changes
Other Study ID Numbers: 2017584
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jordi Villalba Modol, Corporacion Parc Tauli:
nanofractured autologous matrix-induced chondrogenesis

Additional relevant MeSH terms:
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases