Medacta Corporate | MySpine MC

Minimally Invasive
Patient-Matched
Solutions

RATIONALE

MySpine MC is a 3D printed patient matched solution in the midline cortical approach. Posterior lumbar fusion is driven in a minimally invasive [1,2,3], muscle sparing way, allowing for shorter operating times [11] and a substantial reduction of both radiation exposure [11] and costs [12].
The goal of MySpine MC is to combine an excellent fusion rate with greater predictability of the clinical outcomes.

Minimally disruptive, medialized access with paramedial muscle retraction promotes[1]:

Enhanced muscle preservation[2]
Reduced blood loss[3]
Faster patient recovery[3]
Supradjacent facet preservation[1]

Entry points are located at the pars interarticularis with favourable cortical bone[4].

  • MySpine MC provides highly precise implant positioning which may enable the use of longer screws and larger diameters vs. CBT free hand[5,13]
  • Uncompromised fusion rate[6]
  • May reduce the risk of nerve root injury by means of thorough pre-op trajectory management[7]
  • Accurate pedicle screw positioning: easier access to the safe zone for ALL screws[8,13]
     

Improved bone purchase vs. conventional technique:

  • Reduced screw loosening -69%[9]
  • Significantly increase in pull-out resistance +30%[9]
  • Strong anteroposterior spondylolisthesis correction, -83% slip[10]

Ready to use 3D printed technology in your hands

  • No peri-operative image acquisition, thanks to accurate pre-op planning[11]
  • Smart Technique:
    position the MySpine jig on the corresponding vertebra and prepare the screw path for safe and fast implant positioning

Patients are exposed to a low dose pre-op CT scan, resulting in radiation exposure lower than a single full spine x-ray

Pre-operative planning potentially nullifies the need of intra-operative checks, with dramatic reduction of irradiation[11,13]
Cumulative dose is potentially reduced vs. navigation assisted technique

  • NO expensive capital investment is required
  • No recurrent service cost or disposable kit
  • Rapid Learning Curve for effective accuracy[13]
  • Outpatient Surgery: hospital can potentially capitalize on resources and potentially increase volumes as patients return home immediately[12]
CASE MANAGEMENT

IMAGE ACQUISITION

Low Dose CT scan to deliver 3D reconstruction of individual vertebral anatomy

3D PRE-OP PLAN MANAGEMENT

The surgeon defines optimal implant parameters:
screw diameter, length and trajectory

3D PRINTING MYSPINE MC

3D patient matched Jigs are sent to the hospital

MYSPINE MC MIS SURGERY

Surgery with dedicated MySpine MC system

PUBLICATIONS

[1] Matsukawa K. et al., Incidence and Risk Factors of Adjacent Cranial Facet Joint Violation Following Pedicle Screw Insertion Using Cortical Bone Trajectory Technique, Spine, 2016
[2] Sakaura H. et al., Posterior lumbar interbody fusion with cortical bone trajectory screw fixation versus posterior lumbar interbody fusion using traditional pedicle screw fixation for degenerative lumbar spondylolisthesis: a comparative study, JNS, 2016
[3] Khanna N. et al,. Spine (Phila Pa 1976). 2016 Apr;41 Suppl 8:S90-6. doi: 10.1097/BRS.0000000000001475. Medialized, Muscle-Splitting Approach for Posterior Lumbar Interbody Fusion: Technique and Multicenter Perioperative Results
[4] Gautschi O. et al., Maximal access surgery for posterior lumbar inter body fusion (PLIF) with divergent, cortical bone trajectory (CBT) pedicle-screws: a good option for minimize spine access and maximize the field for nerve decompression, Journal of neurosurgical sciences, 2015
[5] Matsukawa -2nd MORE Japan MySpine cortical Bone Trajectory 2017
[6] Matsukawa - Biomechanics of CBT (internal file)
[7] Regev G etal., Nerve injury to the posterior rami medial branch during the insertion of pedicle screws: comparison of mini-open versus percutaneous pedicle screw insertion techniques. Spine. 20093411239-42
[8] Lamartina C. et al., Pedicle screw placement accuracy in thoracic and lumbar spinal surgery with a patient-matched targeting guide: a cadaveric study, European Spine Journal, 2015
[9] Santoni B.G. et al., Cortical bone trajectory for lumbar pedicle screws, The Spine Journal, 2009
[10] Mori K. et al., Short-Term Clinical Result of Cortical Bone Trajectory Technique for the Treatment of Degenerative Lumbar Spondylolisthesis with More than 1-Year Follow-Up, Asian Spine Journal, 2016
[11] Farshad M. et al., Accuracy of patient-specific template-guided vs. free-hand fluoroscopically controlled pedicle screw placement in the thoracic and lumbar spine: a randomized cadaveric study, European Spine Journal, 2017
[12] Chin K.R., Clinical Outcomes With Midline Cortical Bone Trajectory Pedicle Screws Versus Traditional Pedicle Screws in Moving Lumbar Fusions From Hospitals to Outpatient Surgery Centers, Clinical Spine Surgery, 2017
[13] Kaito T., Cortical pedicle screw placement in lumbar spinal surgery with a patient-matched targeting guide: A cadaveric study, Journal of Ortopaedic Science, 2018

[a] Lange et.al. Estimating the effective radiation dose imparted to patients by intraoperative cone-beam computed tomography in toracolumbar spinal surgery, Spine 2013
[b] US Nuclear Regulatory Commission’s (USNRC) 
[c] Lange et.al. Estimating the effective radiation dose imparted to patients by intraoperative cone-beam computed tomography in toracolumbar spinal surgery, Spine 2013 
[d] Biswas et.al. Radiation Exposure from Musculoskeletal Computerized Tomographic Scans, JBJS Am. 2009 
[e] Health Physics Society Specialists in Radiation Safety, Lawrence Berkeley National Laboratory; Fact Sheet 2010 
[f] Radiation Dose in X-Ray and CT Exams; 2013 Radiological Society of North America, Inc 
[g] MySpine, Charité University Hospital, Berlin, Germany 

 

SYNERGY

MySpine MC, together with the MUST Screw System, the MectaLIF Family of Interbody Fusion Devices and our Suite of Specialized Surgical Instruments, create a harmonized and complete system

MYSOLUTION

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MyHip is a system providing 3D preoperative planning and patient-specific guides, developed following the success of Medacta Patient Matched Technology

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MyShoulder is a patient-specific instrumentation, allowing the surgeon to realize his pre-operative 3D planning, based on CT images of the patient’s shoulder. The pre-operative 3D planning allows to manufacture an humeral resection guide and a glenoid positioning guide.
This innovative concept combines different features giving potential benefits to both the surgeon and to the patient.

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