Inion S-1TM Graft Containment System

Training Presentation

December 2015

Table of contents

What is the Inion S-1™ system Indications Products Basic spinal anatomy Inion S-1™ features and benefits Surgical technique Clinical references

What is Inion S-1™?

A biodegradable graft containment system for anterior cervical discectomy and fusion (ACDF) Single and double level plates with radiopaque tantalum markers Screws with radiopaque tantalum markers

What is Inion S-1™?

Made out of LPLA/DLPLA (i.e., combination of L-lactic acid and DL-lactic acid)

Implants retain min. 80% of their initial strength minimum 16 weeks Biodegrades completely in 2-4 years

H2O and CO2

Where Inion S-1™ is used?

Cervical spine (C2-T1) Anterior approach Anterior cervical discectomy and fusion

procedures (ACDF) C2-T1

Indications

Indications

In conjunction with adjunctive immobilisation (i.e., simultaneous conservative treatment with a collar), intended for use in anterior cervical discectomy and fusion procedures as a means to maintain the relative position of block bone allografts or autografts.

Indication

Anterior cervical discectomy and fusion procedures (ACDF), not for load bearing indications.

Inion S-1TM plates and screws

Article No Description Pcs./ packPlates

SPN-5110 Single level plate, 21x19x2.0 mm 1SPN-5111 Single level plate, 23x19x2.0 mm 1SPN-5112 Single level plate, 25x19x2.0 mm 1SPN-5113 Single level plate, 27x19x2.0 mm 1SPN-5114 Single level plate, 29x19x2.0 mm 1SPN-5115 Single level plate, 31x19x2.0 mm 1SPN-5116 Double level plate, 33x19x2.0 mm 1SPN-5117 Double level plate, 36x19x2.0 mm 1SPN-5118 Double level plate, 39x19x2.0 mm 1SPN-5119 Double level plate, 42x19x2.0 mm 1SPN-5120 Double level plate, 45x19x2.0 mm 1SPN-5121 Double level plate, 48x19x2.0 mm 1

ScrewsSPN-5320 Screw 4.5x12 mm 2SPN-5321 Screw 4.5x14 mm 2SPN-5322 Screw 4.5x16 mm 2SPN-5323 Screw 5.0x12 mm 1SPN-5324 Screw 5.0x14 mm 1SPN-5325 Screw 5.0x16 mm 1

Diameter 4.5 mm screws are the primary screws. Diameter 5.0 mm screws are the emergency screws.

Inion S-1TM instruments Article No Description Pcs./ pack Pcs./setINS-9540 Drill bit 3.7 mm with stop for 12 mm screw 1 1INS-9541 Drill bit 3.7 mm with stop for 14 mm screw 1 1INS-9542 Drill bit 3.7 mm with stop for 16 mm screw 1 1INS-9543 Drill bit 4.2 mm with stop for 12 mm screw 1 1INS-9544 Drill bit 4.2 mm with stop for 14 mm screw 1 1INS-9545 Drill bit 4.2 mm with stop for 16 mm screw 1 1INS-9546 Bone tap 4.5 mm with stop for 12 mm screw 1 1INS-9547 Bone tap 4.5 mm with stop for 14 mm screw 1 1INS-9548 Bone tap 4.5 mm with stop for 16 mm screw 1 1INS-9549 Bone tap 5.0 mm with stop for 12 mm screw 1 1INS-9550 Bone tap 5.0 mm with stop for 14 mm screw 1 1INS-9551 Bone tap 5.0 mm with stop for 16 mm screw 1 1INS-9552 Drill bit 2.0 mm 1 1INS-9553 Screw removal instrument 1 1INS-9554 Drill guide, single 1 1INS-9555 Drill guide, twin 1 1INS-9556 Plate holder 1 1INS-9527 Temporary fixation screw 1 3INS-9558 Screwdriver shaft for temporary fixation screw 1 1INS-9559 Screwdriver shaft 1 1INS-9560 Awl 1 1INS-9024 Plate bending pliers 1 2INS-9120 Screwdriver handle, cannulated 1 2INS-9121 Screwdriver handle, ratchet 1 1ACC-9823 Plate template, 21 x 19 mm 1 1ACC-9824 Plate template, 23 x 19 mm 1 1ACC-9825 Plate template, 25 x 19 mm 1 1ACC-9826 Plate template, 27 x 19 mm 1 1ACC-9827 Plate template, 29 x 19 mm 1 1ACC-9828 Plate template, 31 x 19 mm 1 1ACC-9829 Plate template, 33 x 19 mm 1 1ACC-9830 Plate template, 36 x 19 mm 1 1ACC-9831 Plate template, 39 x 19 mm 1 1ACC-9832 Plate template, 42 x 19 mm 1 1ACC-9833 Plate template, 45 x 19 mm 1 1ACC-9834 Plate template, 48 x 19 mm 1 1ACC-9802 Inion Thermo drape 5ACC-9810 Inion Thermo+ (water bath 230V) 1 1ACC-9817 Water bath cable (UK plug) 1ACC-9841 Sterilization tray for instruments 1 1

Color coding of the Drill bits and the Bone taps

The Drill bits and the Bone taps are color coded. Color code is specific for screw length and diameter. Green Screw length 12 mm Blue Screw length 14 mm Magenta Screw length 16 mm One color stripe Screw diameter 4.5 mm Two color stripes Screw diameter 5.0 mm (emergency screw)

Basic spinal anatomy

Between each vertebral body there is an intervertebral disc.

There are 2 parts to the discs: Annulus fibrosus (outer) Nucleus pulposus (inner)

Basic spinal pathology

Degenerative

The term “degenerative” refers to a condition resulting from the loss of normal structure and function.

The spinal structures most affected by degenerative disease are intervertebral discs and facet joints.

Trauma

Trauma

Due to an accident

Note: Inion S-1TM is not indicated to fixation of unstable spine

Benefits – Load sharing with graft

Plate-screw construct is semirigid and ”viscoelastic” (polymer characteristic)

Material ”gives in” under constant load Allows load sharing with the graft

The construct’s modulus of elasticity is close to that of the bone

Allows micromovement

x

37C

F

Rigid or dynamic? – Strong or strong enough?

Vertebral bodies Graft Cervical plate

Load transferred through the graft

Immediately post op

Rigid or dynamic? – Strong or strong enough?

Graft shrinks

Load transferred through the plate

Immediately post op Rigid plate Follow-up

Rigid or dynamic? – Strong or strong enough?

Graft shrinks -> Stress on the plate and graft is shielded

Immediately post op Rigid plate Follow-up

Rigid or dynamic? – Strong or strong enough?

Plate adjusts

Load transferred through the graft

Immediately post op Rigid plate Follow-up

Dynamic plate Follow-up

Rigid or dynamic? – Strong or strong enough?

Benefits – Constrained screw plate design

Screw is fixed to the plate at a chosen angle (+/- 5° recommended) when fully inserted

Allows optimal screw angulation and monocortical screw fixation

”Custom Implants”

Translucent

”See through plate”

Radiolucent

Interference with imaging techniques is eliminated due to low material density

Consequently, the fusion result can be assessed easier

No disturbance in MRI

X-RAY

Radiolucent

Interference with imaging techniques is eliminated due to low material density

Consequently, the fusion result can be assessed easier

No disturbance in MRI

Inion S-1™ Titanium

X-ray

MRI

Degradation – strength retention

Degradation – mass loss

Surgical technique

Open the sterile drape peel pouch and unfold the sterile drape onto a sterile table.

The scrub nurse places both hands inside the sterile drape pouch while the circulating assistant inserts the water bath against the drape’s closed end.

The sterile drape pouch is turned inside out. The opening of the sterile pouch remains around the power cable.

Water bath set-up instructions (1/3)

The water bath is now ready to be placed on a sterile table close to the operating surgeon.

After placing the draped water bath on the sterile table, make a depression into which sterlile water or saline can be poured. Ensure that the drape lines the bottom of the water bath and that no air is left between the drape and the water bath basin. This is important to ensure correct temperature of the sterile fluid during procedure.

Note! Use Inion Thermo + water bath with the Inion S-1 ™ (T: 70°C / 158°F).

6 6

Water bath set-up instructions (2/3)

Pour sterile water or saline into the bath. Fill the bath just over half full (ca. 0.5l). Remember to ensure that this amount of fluid is in the bath during the procedure. Once more ensure there is no air between the bath and the sterile drape.

Once fluid is in the bath, plug the cable in.

The water bath can now be switched on.

Note! Heating of the water takes ~30minutes.

7 7

9 9

Water bath set-up instructions (3/3)

Plate selection and contouring

1. Determine the correct plate size with the plate template.

2. Precondition the Inion S-1™ plate in the Inion Thermo+ water bath for approximately 1 minute. Preconditioning can be repeated up to 3 times. Maximum total immersion time is 30 minutes. (Note: Do not put the Inion S-1™ screws in the hot water bath.)

3. Contour the plate to the bone anatomy immediately after preconditioning. The plate is malleable for approximately 10 seconds after taken out from the water bath.

Drilling and tapping

4. Insert the temporary fixation screws to fix the Inion S-1™ plate on the bone. Two temporary fixation screws are used, one in each end of the plate. Create starting holes with the Awl before inserting the temporary fixation screws.

5. Select the correct size Drill bit and drill the screw hole in the plate and bone through the Drill guide. Drill until the stop of the Drill bit meets the end of the Drill guide.

6. Tap the screw hole through the Drill guide. Tap until the stop of the Drill bit meets the end of the Drill guide. Flush the hole with sterile water or saline.

Insertion of the Inion S-1™ screws

7. Insert the first Inion S-1™ screw through the drill guide. Ensure you maintain downward pressure on the plate using the Drill guide and the screw using the Screw driver. Continue screw insertion until resistance increases and the head of the screw is fully encaged into the plate. Do not overtighten the screw as this may lead to head or thread stripping.

8. Repeat the steps 5 to 7 for the second Inion S-1™ screw. Once you have positioned and Inion S-1™ screw in each end of the plate, remove the temporary fixation screws and repeat the steps 5 to 7 for the remaining screw holes to ensure complete fixation.

Clinical results

Inion S-1™

The Inion S-1™ system was launched in 2005 and since then more than 4500 Inion S-1™ plates have been sold globally.

Approximately 2500 operations have been performed by 2015.

Dr. Nabhan - Inion S-1™

Nabhan et al., J Spinal Disord Tech 22: 155-161, 2009 A prospective, randomized, controlled clinical trial with

37 patients comparing bioresorbable (n=19) and titanium (n=18) plate fixation in single-level ACDF.

Follow-up included a visual analog scale (VAS) with regard to brachial pain and Neck Disability Index (NDI) for neck pain. Success of the procedure was evaluated by radioisometry (immediately postoperatively and after 6 weeks, 3, 6 and 12* months), MRI of cervical spine (immediately postoperatively and at 3, 6 and 12* months) and computed tomography.

Satisfactory clinical results were achieved in both groups without differences in fusion rates or speeds. No complications like soft tissue inflammation, swelling or infection were observed.

* Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008)

Study design

Results

Results

Results

Dr. Rodrigo & Dr. Calatayud - Inion S-1™

Rodrigo et al., 2015 * Long-term evaluation of 17 ACDF patients (10

female, 7 male, mean age 45, 13 single-level and 4 double-level procedures, most common level C5-C6)

Follow-up time 5 – 7 years (2006 -2013) No complications such as edema in adjacent

tissues or long-term infections. All segments fused. None of the patients had to

be reoperated due to failure or migration of the implants.

The Inion S-1™ implants degrade and are replaced by bone.

* Clinical Neurology and Neurosurgery 136 (2015) 116–121

3D CT image 3,5 years postoperatively

Fusion has occurred and the Inion S-1™ plate and screws have completely degraded.

Rodrigo, Calatayud, et al., Zaragoza, Spain

Postoperative 3D CT images

3,5 years postop.

1 year postop.

Dr. Franco - Outcome comparison of ACDF with and without bioresorbable plates

Use of resorbable implants for symptomatic cervical spondylosis: experience on 16 consecutive patients Franco et al. J Neurosurg Sci 2007; 51:169-75

Materials and Methods • Inion S-1 • 29 patients (16 with plates and 13 without plates) of

degenerative cervical spondylosis • 12-15 months

To be continued

Results Outcomes

• Increased stability and fusion rate when a cervical plate was used

• No interference with PO neuro- radiological images

• Continuous load transferring from resorbable plates to the graft and

osteoligamentous spine during resorption

Dr. Tomasino - The radiological and clinical outcomes of the bioabsorbable plate for ACDF Bioabsorbable instrumentation for single-level cervical degenerative disc disease: a radiological and clinical outcome study Tomasino et al. Journal of Neurosurgery: Spine, 2009; 11(5):529-537

Materials and Methods • Inion S-1 plates • 29 patients of cervical radiculopathy spondylosis or myelopathy • 6 weeks to 12 months clinical follow up

To be continued

Results Outcomes

Absorbable plates provides better stability than the absence of a plate No device-related complications, hardware failure and adverse tissue reaction caused

by the implant The fusion rate and outcome are comparable to the results achieved with metal plates

Inion S-1™

1. Load is gradually transferred to the graft as the plate degrades

2. “See through plate”

Intraoperatively – translucent

Postoperatively – no imaging interference

3. Allows easy adjacent level procedures

4. Straight-forward surgical technique and all needed instruments provided in one well organized instrument tray