Step 1: Define the procedure

Step 2: Upload the patient CT to our secured cloud

Step 3: Receive a comprehensive 3D report including recommended screw for each anchorage sizes & Fmax-G in N, lb or Kg for each pedicle for all each targeted level and loadsharing proposal

Step 4: Plan extension, selective or full augmentation bearing the expected operation peak forces.

Precision for screw insertion is a key issue whether the technique is free-hand or navigated. There are many possible insertion trajectories. As a result, each theoretical trajectory does not have the same strength since the bone density varies within the pedicle and anterior body.

PedicleForce simulates all relevant breachless trajectories with the full range of your vendor screw set in diameter and length and predict each resulting anchorage.

Then PedicleForce selects the unmissable result for breachless trajectories: the baseline guaranteed construct prediction for each possible screw size of the whole screw range given the actual screw will be inserted breachless.

The new paradigm: FMax-G = the baseline FMax you can rely on for planning independly from the insertion technology precision.

PedicleForce deals with the interpersonal and even individual inter-vertebral bone density distribution variation with a vertebra patient-specific assessment

These bone density distribution variations are potentialized by the actual peroperative screw trajectory unpredictibility.

As a result, material failure like screw loosening, screw pullout, PKJ/PKF, debricolage and pseudoarthrosis, are hard to prevent.

Classical global indicators like DEXA T-Score, FRAX® ou TBS®, patient's status and operator's experience are important, but still poor clinical outcome predictors.

FMax-G is derived from FMax.
FMax-G: baseline anchorage prediction with ρ=.99

FMax is a widely admitted indicator for pedicular screw fixation systems apraisal.
FMax is the maximum experimental axial load (N) applied on an inserted screw;
any additional load is causing the progressive bone/screw interface destruction.

Symetrically, FMax-G reflects the safe pedicular insertion strength capability for a given screw size and design.

PedicleForce has been developped after academic fundamental explorations with non clinical methods for accuracy golden standard definition (FEM +88µm µCT) ^[1] and meticulous innovative methodology in pullout testing for standard, fenestrated and expendable pedicular screws.
PedicleForce has be confirmed by the in vitro golden standard testing: a 45 cadaveric vertebrae screw pullout with an accuracy of ρ = .99

Cook, 2004: Augmentation gives up to 250% more strength ^[2], with a leakage risk for each screw. If underused, a sole bad anchorage may cause material failure. Global indicators like T-Score are poor predictors.

The new paradigm: Assessing the augmentation benefit/risk balance with Fmax-G, the Pedicle-Specific Predictor.

Yongjung, 2008: PJK occurs in as many as 39% of postoperative adult deformity patients, with a majority occurring within the first 6 to 8 weeks of surgery. ^[2]

Screw anchorage is a key issue for PKF/PKJ prevention or postponement:

Goldstein, 2015: "Osteoporosis can have a significant impact on the strength of spinal fixation as well as complication rates related to hardware failure and PJK/PJF. Evidence exists to support the use of increased points of fixation through the use of multilevel pedicle screws as well as consideration of cement augmentation, using either a fenestrated or solid screw technique. Further, in patients with compromised BMD, cement augmentation of adjacent uninstrumented levels may be of benefit ^{[3] []4 [5] [6] [7]}.

PedicleForce interfaces with insertion masks, nav and robotics using 3D Imagery worls coordinates and mesh.