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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
Sponsor:
Information provided by (Responsible Party):
Jordi Villalba Modol, Corporacion Parc Tauli

Tracking Information
First Submitted Date July 10, 2018
First Posted Date August 10, 2018
Last Update Posted Date August 10, 2018
Actual Study Start Date July 18, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 2018)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 9, 2018)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational, Prospective Study of Patients With Chondral and/or Osteochondral Defects of the Knee Treated With NAMIC
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
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

Detailed Description

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 be performed in most hospitals to improve clinical outcomes of patients with severe chondral lesions.

The present observational, multicentre study is based on the recently published NAMIC© technique (Behrens_Bentin_06_2015 The Knee) that reports significant improvements over previous techniques, especially regarding the reduction of rehabilitation period. Our main aim is to confirm these results in a larger sample.

NAMIC is a matrix-guided minimally invasive stimulation of the subchondral bone marrow.

The present study will collect data on the usual medical practice when the NAMIC technique is used to treat grade III or IV symptomatic focal cartilage lesions.

According to Chen 2011 JOR 2011, nanofracture achieves a uniform blood drainage and pluripotential cell recruitment of the bone marrow through the depth of the 9mm perforations. As observed by Eldracher AJS 2014, it also allows a faster recovery thanks to the minimal aggression on the subchondral bone as the diameter of the drill holes is 1 mm.

According to the study published by Benthien JP, in Knee Surg Sports Traumatol Arthrosc 2011 Aug:19(8):1316-9, AMIC induces satisfactory chondrogenesis.

To date, the combination of nanofracture plus Cartimaix membrane has not been used in patients in our environment.

Hypothesis: The NAMIC technique is useful for the treatment of chondral lesions of the knee.

Objectives:

Main: Determine the decrease of lesion size and the regeneration of chondral tissue in femoral condyle cartilage defect treated with NAMIC.

Secondary: Assess the clinical results regarding pain, articular rigidity and function before surgery and 12 months postoperatively.

Description of technique: After localization of the chondral lesion, 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).

Nanofracture is a subchondral bone perforation procedure using a 1mm-thick needle, with a depth of 9mm, 2mm apart , in a systemic spiral fashion in the whole periphery of the lesion, using a specially-designed kit (Nano FX, Arthrosurface, USA). It allows a reproducible, effective and minimally invasive stimulation of the subchondral bone. Nanofracture achieves a uniform blood drainage and pluripotential cell recruitment of the bone marrow through the depth of the 9mm perforations.

Subsequently, the lesion is traced with a template included in the kit (Cartimaix, Matricel, Germany), and the membrane is cut to the adequate size, bearing in mind that it expands 10% with hydration. The two-layer membrane is then implanted on the lesion, and left to be hydrated by the blood from the stimulated area (Image 2). Cartimaix is a two-sided type I/ III collagen and elastine membrane that includes a smooth side (intraarticular) and a rough side facing the cartilage. Finally, fibrin sealing is achieved (Tissel, Baxter, USA). This technique can be combined with a graft in osteochondral injuries, but these are not contemplated in the present study.

Variables:

Main variable: 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.

The following information will be collected: a) size and localisation of the lesion; b) alignment determined by telemetry; c) surgeries of cartilage or that may directly or indirectly affect cartilage such as meniscectomy, osteotomy, microfracture, mosaicoplasty or ligament repair.

A series of intraoperative pictures will be collected.

Secondary variables:

Pain: Visual analogue scale (VAS) Function and articular rigidity: KOOS scale, Tegner Activity Scale during routine outpatients visits, at preoperative visit and at 12 months.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Chondral Defect
  • Osteochondral Defect
Intervention 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).
Study Groups/Cohorts Treatment
NAMIC technique
Intervention: Biological: NAMIC: nanofractured autologous matrix-induced chondrogenesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 9, 2018)
24
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03625180
Other Study ID Numbers 2017584
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jordi Villalba Modol, Corporacion Parc Tauli
Study Sponsor Jordi Villalba Modol
Collaborators Not Provided
Investigators Not Provided
PRS Account Corporacion Parc Tauli
Verification Date August 2018