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Global Regenerative Trade

KANFIT3D®

KANFIT 3D Clinical Cases and Medical Design. PRESURGICAL MODELS

WHAT IS PATIENT SPECIFIC IMPLANT?

Young people who do not have inherent pathologies, clinically differ by the size of their bones and certain geometric variations. However, there is a wide range of clinical cases of people who suffer from acquired disorders of the musculoskeletal apparatus. The more severe the disorder is, the larger its diversity. Therefore, the more serious the condition of the patient, the more s/he needs a more complex patient-specific implant: joint, spinal, facial, cranial or osteosynthesis implant.

Even though surgeons attempt to recreate the human anatomy and functionality from what they have, what is distributed by standard implant manufacturer, the clinical condition treatment results using standard and patient-specific implants are completely different. Patient-specific implants are irreplaceable when a part of a bone needs to be removed due to oncological cases, when performing revision joint replacement surgeries, in cases of complex traumas and severe, acquired or congenital defects of the skeleton. Since current orthopaedic, neurosurgical and maxillofacial surgeries are becoming more and more complex, the need for patient-specific implants that would suit a particular patient’s clinical case is growing.  

Patient-specific implants have become more accessible with the emergence of additive metal manufacturing technology (3D printing). The first 3D-printed medical grade titanium hip joint endoprosthesis described in the literature was implanted in 2006 in Australia. In the Baltic States, the first patient-specific hip implant was manufactured in 2015 in our company.

The patient-specific implant production method – 3D metal printing – as such gives implants added value because it almost has no limitations in the realisation of one-piece most complex constructions and enables to form trabecular metal surfaces that ensure better secondary fixation of the implant. All other advantages of patient-specific implants compared to standard implants arise from the design and the construction of an individual implant and the level of product personalisation.

Advantages of using patient-specific implants

  • Better treatment results, higher quality of life, higher level of mobility and working capacity;
  • Minimisation or total prevention of treatment-related side-effects;
  • Lower invasiveness of the surgical treatment, lower risks of surgical and postsurgical complications (including infections);
  • Shorter surgery procedure;
  • Faster healing process, shorter postsurgical rehabilitation;
  • Lower risk of revision surgeries;
  • Longer lifespan of implant;
  • Cost efficiencies regarding treatment and incapacity compensation.

KANFIT 3D PSI

CASES

GUN SHOT WOUND

Cemented Couboid

DISTAL FEMUR TREATED WITH PLATE AND CEMENT

NON UNION

TUMOR OF THE PROXIMAL AND MIDSHAFT OF RT. FEMUR

Tumor resection over guides + cage with plate

GIANT CELL TUMOR

Fourth finger

RECONSTRUCTION OF LT. MAXILLA AFTER TUMOR RESECTION

Bone taken from fibula

TUMOR IN L4

En block resection + cage

RECONSTRUCTION OF MANDIBULA

DISTAL TIBIA

3rd revision case distal tibia ankle fusion

Distal Tibia revision case

DISTAL TIBIA AND ANKLE

Cranial Flap

blowout fracture of the orbital

Oral and Maxillofacial Surgery

Full Calcaneus Tarsal replacement RT

ANKLE ARTHRODESIS AFTER MULTI TRAUMA

DISTAL TIBIA AND ANKLE

3D MEDICAL DESIGN, PLANING, VISUALISATION. PRESURGICAL MODELS

CASE STUDIES

Mandibular Reconstruction using Fibula Graft

Custom talus implant

Complex primary hip

Complex shoulder case

Complex Hip Revision

GUN SHOT WOUND

CEMENTED CUBOID

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DISTAL FEMUR TREATED WITH PLATE AND CEMENT

NON UNION

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TUMOR OF THE PROXIMAL AND MIDSHAFT OF RT. FEMUR

Tumor resection over guides + cage with plate

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GIANT CELL TUMOR

FOURTH FINGER

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RECONSTRUCTION OF LT. MAXILLA AFTER TUMOR RESECTION

Bone taken from fibula

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TUMOR IN L4

En block resection + cage

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RECONSTRUCTION OF MANDIBULA

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DISTAL TIBIA

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3rd revision case distal tibia ankle fusion

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DISTAL TIBIA

REVISION CASE

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CRANIAL FLAP

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blowout fracture of the orbita

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ORAL AND MAXILLO-FACIAL SURGERY

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Full Calcaneus Tarsal replacement RT

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ORBITA

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ANKLE ARTHRODESIS AFTER MULTI TRAUMA

DISTAL TIBIA AND ANKLE

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Mandibular Reconstruction using Fibula Graft

Head and Neck cancer accounts to 30% of all cancers diagnosed in India. Oral cancers are the most common among males in our country and fourth most common in females. In India 60-80% of them is present in advanced stage as compared to 40 percent in developed countries.

There is a primary need to understand the tumour location, shape, and size to realise an effective tumour removal followed by accurate reconstruction. The reconstruction is done by either using a customised implant manufactured in bio-inert material or by using patient’s own bone for grafting.

Here is one such case. A male patient of age 43 was diagnosed with cancer whose primary surgery of mandible tumour removal was already done. Due to deficient right mandible, there were difficulties in chewing, speech and for daily activities in public due to discomforting aesthetics.

Dr Raghuvir Solanki, Head and Neck Onco Consultant – Zydus Hospitals, approached our clinical engineers for a robust plan and precise reconstruction of the neo-mandible using the fibula bone of the patient.

We planned to Visualize, Plan, and then execute

Visualisation:

In order to visualise the mandibular anatomy and its neighbouring area, a high-resolution CT scan of adequate slice thickness and increment was used to 3D model the defect. Region of interest was well captured in the scan and replicated as 1:1 digital model for understanding the defect and pathology. Similarly, patient’s left fibula was modelled from the CT scan to harvest the required grafts. The idea is to provide self-explanatory model and help surgeon to make them visualize the information which usually remain hidden in conventional 2D CT images.

Planning:

Once the 3D modelling of the images (segmentation) was completed, a plan was to lay down the reconstruction of neo-mandible using fibula bone.

Key steps involved –

  • Due to deficient region on the right, there was no contact to the right condyle, which resulted in improper occlusion.
  • A proper occlusion was achieved by virtually simulating the correct occlusion state taking references from the mandibular/maxillary teeth and re-positioning the healthy left condyle in the fossa.
  • Then the healthy left mandible was mirrored to achieve best clinical reference for reconstructing neo-mandible

Surgical guide was designed to resect the mandible for a perfect joint connection of new mandible to the healthy left mandible.

Fibula bone was used to reconstruct the defect, following the reference of the mirrored side. This helped in getting the right segments of the fibula, placed at specific angles to form the new mandible for the patient. A surgical guide was designed to execute the exact same cuts intraoperatively.(As shown in below images)

3D Printing:

Once the surgical plan was approved and finalised, the plan was translated to physical models to analyse the outcome. Pre-op, intermediate and post-op models were printed. The patient-specific guides were 3d printed in biocompatible autoclavable material for realising the planned cuts intra-operatively on mandible and fibula bone.

Custom talus implant

Customized Talus Replacement is still a rarity in foot and ankle surgeries in India. However, recent literature shows promising results and mentions advantages like; It avoids LLD (leg length discrepancy), able to achieve a wide range of motion, shortens surgical time, reduces overall logistic cost, optimizes balance with the available range of sizes.

Talus replacement could be used in conditions like osteonecrosis and trauma. We are glad to share one of our customized talus cases in collaboration with a pioneer surgeon in the field of total Talur replacement in India Dr. Rajiv Shah, Head of Foot and Ankle Surgeries, Sunshine Global Hospital, Vadodara.

We planned to Visualize, Plan, and then execute

 

Visualization:

The process begins with accurate CT scan acquisition of bilateral ankle which is significant for radiological evaluation of deformed talus. Proper traction was ensured during the scan so we can get a better idea actual gap available. Post evaluation, our skilled segmentation team assured that every anatomical information is perfectly converted in 3D model as defined by surgeon.

Planning:

Detailed preop planning is the most important step and plays pivotal role in the outcome of the surgery. Preop planning session with Dr. Shah was particularly very helpful in understanding his perception and intended use. Once the requirement was cleared the complete plan was proposed to him.

Key steps involved –

  • Contra-lateral talus was mirrored and registered with diseased talus using registration tools.
  • Subsequently, we verified the conformity and location of registered talus with diseased neighboring bone. Fact that 70% of talus bone involves in articulation, makes it critical to verify all the peripheral joints alignment wrt. registered talus including tibia, navicular, calcaneus, and fibula.
  • Rotation and flexion of the talus was also evaluated to assure it has been registered in desired alignment
  • Sizing prediction based on the existing gaps was initiated. We provided three sizes with as low as 10% volume difference to original. The sizes were -1, 0 and +1.
  • Range of sizes allow surgeon to select appropriate size after intra-operative assessment of the joint
  • Considering the talus placement could be tedious and cumbersome when placed with hand during the surgery, we also developed detachable long handle which could be used for placing the ankle while trialing different sizes
  • The hole which is used to attach the long handle was closed with anterior screw to restrict blood inside the 3D printed talus.

3D Printing:

Once the plan was approved by the surgeon, the design was transferred for manufacturing. We follow two steps of 3D printing during the first step all the prototypes of design consisting ankle joint with anatomical gap along with trial sizes were provided. These prototypes help surgeon to validate the concepts and gives flexibility in case any last-minute changes required. Once surgeon has provided his approval, final metal 3D printing of talus sizes was manufactured and delivered in non-sterile form.

Conclusion:3D printed talus as a derivation and extension of detailed preop planning is always holds edge over conventional approach and it has been validated in this case. Surgeon was able to achieve his desired results.

Complex primary hip

Introduction :
Unlike other joints, the role of patient specific instruments in THR is less explored. We took this opportunity and developed a product which could help achieve accurate acetabular cup placement. The technology could reduce the error in version and inclination as well as give confidence to surgeon upto what size they can ream. It is also well documented that in cases with massive bone defects, such technology is effective.

Preop evaluation at the hospital:
49/M with the complain of pain in both hip and difficulties in walking. During physical examination it was observed that the patient was struggling to achieve complete range of motion. Pre-op X rays confirmed the arthritis in both hips. The surgeon reached out to Jajal Medical to explore the possibility of performing this case with our cup positioning guide.

Visualize:
CT scan was performed for both the hip using scan acquisition protocol. Region of interest was segmented with our imaging experts, preserving all the anatomical detailing which could have clinical significance. 3D model and animation was shared with surgeon for the initial 3D assessment of the case.

Plan:
Dr. Vivek and our preop experts did extensive preop planning to ensure correct component alignment can be achieved. The requirements from the surgeon were:

• Need a tool for referencing the acetabular component alignment
• Self-explanatory Preop Model for preop assessment
• 3D version and inclination information
• Sizing interpretation and validation through physical template model including for femur
Design inputs was put into execution by preop experts. 3D animated of the planning along with complete planning report was shared.

Print:
The Printable Plan which consisted of acetabular model, component alignment guide, and femur model were dispatched in four working days and well before surgery ensuring the surgeon got enough time to evaluate the model. It was effectively put into execution in clinical environment by Dr. Vivek in following structured and cautious approach:
• Compare and evaluate the physical model with patient anatomy visually in OT. The 3D printed femur head model matched perfectly with actual patient’s anatomy giving confidence that these are very accurate models.
• After clean up of soft tissue the guide for cup positioning was placed
• Ensured that the stability of the guide was achieved before pin placement
• Feedback from the peer surgeons involved in the surgery on the reference pin alignment
• Reaming was done such that the reamer handle was parallel to referencing stiman pins
• Evaluating the size prediction by trials and confirming it with our template
• Evaluating the amount of reaming required by referring the range of reamed bone model

Post op Assessment:
Post-op X-ray images shows that using this cup positioning guide, Dr. Vivek was able to decide component alignment accurately. He also shared the significance of this product for new surgeons who are willing to adapt new and effective way for planning their complex primary cases. It has potential to provide new surgeons a confidence in the OR.

Complex shoulder case

Malalignment of glenoid center pin guide is one of the challenges in Shoulder Arthroplasty. Contextually cases like mentioned here with severely damaged osteoporotic bone are comparatively more challenging. 3D printed glenoid center guide brings immense value while planning these cases. Only planning on CT scan without 3D model may be a compromise with clarity and accuracy. Preop planning with 3D model provides present better case situation in terms bone erosion and angulation tilts. It can also be used as decision making tool in case if they required any augment for the particular case.  Needless to say, It optimizes the drill length and and entry point location for glenoid center pin.

These guides along with scapula model can be also considered a fine training tool for better understanding of cases preoperatively.

Complex Hip Revision

Discomfort of multiple acetabular revision for the patient is unconceivable. It can also be nightmare for the surgeons if not planned precisely. Sharing this case of 6Oyr/M patient, CT assessment shows ruptured medial wall and significant vertical hardware shift.

There was a lot of artifact around the bone due to metal hardware in the CT images. Such cases need precise segmentation avoiding any artifacts and extracting the 3D model from the scan to provide best visualization experience.

As we move from 2D to 3D, it is amazing to see how our clarity and surgeon’s confidence reaches to the next level. It triggers our mind to approach the problem differently. Our expert surgeon panel helped ensure our planning was on track clearing all doubts around cup positioning. Location of all the screws were re-confirmed and a robust execution plan was prepared.

Our approach is always to Visualize, Plan and then execute

Visualisation:

The first stepping stone to understand and get into the core of the problem is by 3D visualization.  For achieving this, we used customized segmentation process overcoming all the challenges like metal artifact, ROI identification issue and preserving the clinically significant regions while creating 3d model.  The idea is to provide self-explanatory model and help surgeon to make them visualize the information which usually remain hidden in conventional 2D CT images.

Planning:

The key element of pre-op planning process is deriving the clear requirement from the surgeon. Below are few design considerations we opted out for this case:

  • – Medial wall distorted, and vertical displacement of hardware was very evident. The information helped surgeon to optimize their decision on component placement
  • – Mirroring from the healthy side provided the references for the cup placement
  • – Performing wall thickness enabled surgeon to identify the denser part of the bone, which eventually was helpful for drilling pin location and optimizing the contact area.
  • – Virtual implant positioning enabled surgeon to decide appropriate implant size and ensure its availability in the surgery including necessary additional augments.
  • – Identification and creation of the patient specific pin guide for home run screw placement can be of significant value
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THE VIVOSTAT® SYSTEM

The uniqueness of the Vivostat® system is a novel patented biotechnological process that enables reliable and reproducible preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

THE FULLY AUTOMATED VIVOSTAT® SYSTEM CONSISTS OF THREE COMPONENTS: