ONE – patient specific solution 

ONE is a patient-specific correction guides solution to accompany you in 2D and 3D planning, as well as in the performance of your osteotomies. 

The ONE solution was initiated by a thesis in 2014 on “Pre-operative planning for osteotomies around the knee – From a three dimensional numerical model to the industrialisation of a patient-specific guide” and is motivated by renewed interest for valgus correction tibial osteotomy. The objective of this thesis is to understand the stakes involved in this surgery, making it more safe and reliable. Thus Newclip Technics worked in close collaboration with orthopaedic surgeons in order to better understand the stakes and their problems. That is how the ONE solution was marketed in 2017 for osteotomies around the knee. 

Since then, the ONE range has been expanded to all lower and upper limb osteotomy indications. 

This product is pending FDA /certification approval, do not hesitate contact us for more information

Advantages 
OF ONE solution

1. Precision 

Solution ONE allows obtaining:

  • A correction precision to the nearest 0.5°
  • Secure positioning of cutting plane 
  • Guaranteed corrections in the 3 planes 
  • Guaranteed plate positioning 

The guides are made according to a “reverse engineering” method 

2. Security 

Solution ONE allows securing:

  • The hinge, especially in the case of lower limb osteotomies   
  • Soft tissues, such as the patellar tendon during osteotomies of the tibia and subclavian arteries during osteotomies of the clavicle 
  • The guides are updated and adjustable to standard instrumentation 

3. Speed

The ONE Solution allows gaining operative time when the learning curve has been attained, because: 

  • The holes are pre-drilled 
  • The cut depth is managed, if necessary
  • The plate positioning is predefined
  • The correction is planned
  • The lengths of the screws are planned 

4. Decrease in the number of fluoroscopy 

The ONE Solution allows reducing the number of fluoroscopies in the operating theatre. 

  • Two fluoroscopies for the positioning of the PSI
  • An optimal fluoroscopy for the depth of cut  
  • Two validation fluoroscopies for validation of final assembly

5. Adaptable

The ONE Solution can adapt itself to surgeons and surgeries with a certain number of options available: 

  • Patient-specific wedge  
  • Ligamentoplasty tunnel   
  • Cutting slit for biplanar osteotomy  
  • A second cutting pin
  • A TTA guide
  • A femoral head cutting guide
  • A iliac crest head cutting guide 
  • A bone substitute head cutting guide  
  • Pre-operative bone  
  • Post-operative bone 

The products of the ONE range

ONE CLAVICLE
ONE ELBOW
ONE FOREARM
ONE WRIST
ONE KNEE
ONE ANKLE
ONE FOOT

ONE timeline

Start of the process : Creation of case on platform.

To order a correction guide, you must order it through the reservation platform. To start a case, the following information is required:

  • The side to be operated 
  • The type of surgery envisaged  
  • A CT-scan according to the Newclip protocol of the indication  

The following information may be communicated at a later date: 

  • Date of surgery
  • Plate desired 
  • Options requested

Second step : Review of acceptance of case.

Once submitted, the case is reviewed at the Patient Specific department to verify:

  • The patient data from CT scan in accordance with the data recorded during the order
  • The DICOM format of the CT scan
  • The quality of the CT scan 
  • The thickness of the cuts 
  • Compliance with Newclip protocol

D-19to D-10 – First simulation to validation of the dossier

Once the case has been accepted, you will receive an initial simulation dossier (measurements and/or simulation of correction) 19 working days before the date of your surgery.  

You should then validate it or ask to modify: 

  • The position of the cutting plane 
  • The correction in the 3 planes
  • The positioning of the plate
  • The choice of the plate 

D-9 to D-5 : Design of the guide, printing and shipping

Once you validate the correction simulation, the team can then design the correction and associated options. It will be printed, cleaned and then sent a week before your surgery.  

Surgery

On the day of the surgery you will have:

  • The standard kit containing the plate required 
  • The patient specific guide 
  • Options requested 
  • The standard instruments to be used with the correction guide 
  • The surgical technique
  • A surgical assistance (if desired)

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The purpose of this information is to present the Newclip Technics range of medical devices. These products must be handled and/or implanted by trained and qualified personnel who have read the instructions for use. The surgeon remains responsible for his or her own professional and clinical judgement prior to the use of specific products on a given patient.