Stryker T2 Operative Technique

Operative Technique
KnifeLight
Carpal Tunnel Ligament Release
T2
Recon Nailing System R2.0
Operative Techn ique
Hip & Femur Fractures
Femur
T2 Recon Nailing System
We greatly acknowledge and appreciate the contributions to this operative technique made by:
Kevin W. Luke, M.D.
Parkview Orthopaedic Group Assistant Clinical Professor Department of Orthopaedic Surgery University of Illinois Illinois, Chicago USA
Anthony T. Sorkin, M.D.
Rockford Orthopaedic Associates, LLP Clinical Instructor Dep. of Surgery University of Illinois College of Medicine Director Orthopaedic Traumatology Rockford Memorial Hospital Rockford, Illinois USA
Ariaan D.P. van Walsum, MD
Trauma surgeon Medical Spectrum Twente Enschede Netherlands
Don Weber, MD, FRCSC
Associate Clinical Professor of Orthopaedics Chief of Orthopaedics University of Alberta Hospital Edmonton, Alberta Canada
Contributing Surgeons
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This publication sets forth detailed recommended procedures for using Stryker Osteosynthesis devices and instruments.
It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required.
A workshop training is required prior
to first surgery.
All non-sterile devices must be
cleaned and sterilized before use.
Follow the instructions provided in
our reprocessing guide (L24002000).
Multi-component instruments must
be disassembled for cleaning. Please refer to the corresponding assembly/ disassembly instructions.
See package insert (L22000007) for a complete list of potential adverse effects, contraindications, warnings and precautions. The surgeon must discuss all relevant risks, including the finite lifetime of the device, with the patient, when necessary.
Warn ing :
Fixation Screws: Stryker Osteosynthesis bone screws are not approved or intended for screw attachment or fixation to the posterior ele­ments (pedicles) of the cervical, thoracic or lumbar spine.
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Contents
Page
1. Introduction & Features 5
Implant Features 5
Technical Specifications 6 Instrument Features 7
2. Indications, Precautions & Contraindications 8
3. Pre-operative Planning 9
4. Locking Options 10
5. Operative Technique 11
Patient Positioning and Fracture Reduction 11
Incision 11 Entry Point 12 Re a ming 14 Nail Selection 16 Assembly of the Targeting Device and the Nail 17 Nail Insertion 18 Final Seating with Impactor 18 Guided Locking for the Recon Mode 19 Guided Locking for Antegrade Femoral Mode 29 Freehand Distal Locking 32 Set Screw or End Cap Insertion 34 Nail Removal 34
Ordering Information – Implants 35
Ordering Information – Instruments 37
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Introduction
Over the past decades antegrade and retrograde femoral nailing have become widely accepted choices for the treatment of femoral fractures.
The T2 Recon nail is one of the first femoral nailing systems to offer a greater trochanter entry point with both recon and antegrade locking options.
Through the development of a common, streamlined instrument system and intuitive surgical approach, both in principle and in detail, the T2 Recon Nail offers the potential for more efficient treatment of fractures as well as simplifying the training requirements for all person nel involved.
Furthermore, the T2 Recon Nail offers the following competitive advantages:
• Versatility-offerstheabilityto
switch from antegrade to a recon option without changing either
the nail or targeting arm.
• ReconSetScrew-thisoptional
screw sets the most proximal Lag Screw thus minimizing the potential for screw sliding (Z-effect).
• LockingOptions-distaloptions
include dynamic as well as static.
• DistalTargeting-eliminatesthe
need for freehand locking of either the static or dynamic modes.
RequiresoptionalGamma3/T2 ReconDTSR2.0
The T2 Recon Nail is the realization of excellent biomechanical intrame­dullary stabilization for internal femoral fixation with several locking options to address fracture variability.
As with all other T2 Nails, the T2 Recon Nail is made of Type II
anodized Titanium Alloy (Ti6Al4V) for enhanced biomechanical and biomedical performance*.
The T2 Recon Nail features a 125°
CCDanglewitha10°anteversion
angle. The 2 proximal holes, each utilize 6.5mm cannulated Lag Screws. This CCDangle allows easy
insertion of the 2 lag screws into the femoral head.
Alternatively a proximal 70° Oblique hole with 7° retroversion provides a 5mm Fully Threaded Screw for targeting the lesser trochanter in the Femoral Antegrade mode.
The 6.5 mm Cannulated Lag Screws
have a unique thread design that provide an excellent grip. Improved front cutting flutes allow for lesser insertion torque and thinner flanks for less bone removal.
Secure placement of the Lag Screws within small neck diameters can be achieved due to 10mm separating the two 6.5mm lag screws or 17mm outer distance between the 6.5mm Lag screws.
Two Set Screws are available:
- Recon Set Screw: Tightens the
6.5mm proximal Lag Screw (Recon Mode) and
- Antegrade Set Screw: Tightens the oblique 5mm Fully Threaded Screw (Femoral Antegrade Mode).
Available as left and right versions, the T2 Recon Nail incorporates an antecurvature radius of 2.0M, as well as a 4° medial lateral bend for trochanteric insertion.
The distal locking configuration features a round and an oblong hole to allow for staticand/ordynamic
distal locking.
Low profile 5mm cortical screws,
common to the T2 Nailing System, are designed to simplif y the surgical procedure and promote a minimally invasive approach.
5mm Fully Threaded Locking Screws are available for distal locking (Recon or Femoral Antegrade Mode) and for the proximal locking in Femoral Antegrade Mode.
End Caps are available in various lengths to provide a better fit.
See the detailed chart on the next page for the design specifications and size offerings.
Implant FeaturesIntroduction
* Axel Bauman n, Nils Zander, Ti6Al4V with
Anodization Type II: Biological Behaviour and Biomecha nical Effects, White Paper, March 2005.
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Introduction
NailDiameter 9, 11, 13 and 15mm (Left and Right) Sizes 280−480mm, in 20mm increments
Note:
Proximal diameter is 13mm for
the 9 and 11mm Nails and 15mm for the 13 and 15mm Nails.
Check with your local
representative regarding availability of nail sizes.
5.0mm Fully Threaded Locking Screws
L = 25–120mm
6.5mm Cannulated Lag Screws
L = 65–130mm
Antegrade Set Screw
End Caps
Stand ard +5mm +10mm +15mm
0mm
Antecurvature radius 2.0M
40mm
20mm 15mm
0mm
4° Medial Lateral bend
44mm
70°
125°Nail angle
0mm
26mm
10.5 mm
Technical Specifi cations
Recon Set Screw
17.0 mm
Note:
Screw length is measured from top of head to tip.
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Introduction
Instrument Features
A major advantage of the T2 instrument platform is the integration of core instruments that can be used not only for the complete T2 Nailing System, but for future Stryker Osteosynthesis nailing systems, thereby, reducing complexity and inventory.
The T2 instrument platform offers
precision and usability, as well as ergonomically styled targeting devices.
Except for the addition of a small number of dedicated instruments, the T2 Femur instrument platform is used for the T2 Recon Nail.
The T2 Recon targeting device is designed to provide two proximal locking options: Recon or Antegrade Femoral Modes.
Reconmode: Provides two (2) proximal holes targeting the femoral neck and head:
• B Targets the Proximal Recon
6.5 mm Lag Screw
• A Targets the Distal Recon
6.5 mm Lag Screw
Antegrade Femoral Mode : Provides a single 5mm Oblique Screw targeting the lesser trochanter. LEFT is used for a left nail and RIGHT for a right nail.
With the exception of the carbon fi ber targeting device, dedicated instruments for the recon mode are color coded with “bronze”. This makes it easy to differentiate them from the core T2 instrument platform.
Drills
Drillsfeaturecolorcodedrings:
4.2mm = Green
(Consistent with the Gamma3 and T2 Instrument Plat form, this drill features a green color ring.) The 4.2mm drills are used for 5.0mm Fully Threaded Locking Screws (either for distal locking or for proximal oblique locking).
6.5mm
The Solid Stepdrill for the Lag Screw is color coded with “bronze”.
Targeting holes for Recon Mode
B
A
Targeting holes for Antegrade Femoral Mode
Left
Right
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Indications, Precautions & Contraindications
Indications
The T2 Recon Nail is indicated for:
• Subtrochanteric fractures
• Intertrochanteric fractures
• Ipsilateral neck/shaft fractures
• Comminuted proximal femoral
shaft fractures
• Femoral fi xation required as a result of pathological disease
• Temporary stabilization of fractures of the femoral shaft ­ranging from the femoral neck to the supracondylar regions of the femur.
Precautions
Contraindications
The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include:
• Any active or suspected latent infection or marked local infl ammation in or about the affected area.
• Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
• Bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fi xation of the devices.
• Material sensitivity, documented or suspected.
• Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fi xation of the device or to failure of the device itself.
Stryker Osteosynthesis systems have not been evaluated for safety and use in MR environment and have not been tested for heating or migration in the MR environment, unless specified otherwise in the product labeling or respective operative technique.
Antegrade Mode
Recon Mode
• Patients having inadequate tissue coverage over the operative site.
• Implant utilization that would interfere with anatomical structures or physiological performance.
• Any mental or neuromuscular disorder which would create an unacceptable risk of fi xation failure or complications in postoperative care.
• Other medical or surgical conditions which would preclude the potential benefi t of surgery.
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An X-Ray Recon Template (1806-3080) is available for pre-operative planning. Thorough evaluation of pre-operative radiographs of the affected extremity is critical. Careful radiographic examination of the trochanteric region and neck regions can reduce the potential of intra-operative complications.
Note:
TheX-RayReconTemplate
features a scale of 1.15:1 which is adapted to conventional
analoguousX-Rays.Fordigital X-Rays,attentionhastobe
paid that the magnification is corresponding with the template.
According to the fracture type either Recon or Antegrade Femoral Mode can be chosen.
Evaluation of the femoral neck angle on the pre-operative X-Rays is mandatory as the T2 Recon Nail has a fixed 125° neck angle for the two Lag Screws. Proper placement of both Lag Screws in the femoral head is essential.
If possible, X-Rays of the contralateral side should be used to determine the normal neck angle and length of the femur.
The proper nail length should extend from the tip of the greater trochanter to the epiphyseal scar.
Note:
Check with your local representative regarding availability of nail sizes.
Pre-Operative Planning
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Locking Options
The T2 Recon Nail can be locked proximally with two 6.5mm Lag Screws (Recon Mode, Fig. 1) or with one 5mm Fully Threaded Screw (Antegrade Femoral Mode, Fig. 2).
For both Recon and Antegrade Femoral applications, depending on fracture pattern, either static or dynamic distal locking can be used.
Fig. 1
Fig. 2
Recon Mode
Antegrade Femoral Mode
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Operative Technique
Fig. 3
Fig. 5
Fig. 4
Patient positioning for T2 Recon Nail insertion is surgeon dependent. However, it is recommended that patients are positioned in either the supine or lateral position on a fracture table to allow closed reduction of the frac ture (Fig. 3).
Manipulate and reduce the fracture in the usual fashion, according to the fracture type. Reduction should be achieved as anatomically as possible. If this is not possible, reduction in one plane should be complete, leaving reduction in the other plane to be achieved prior to reaming and nail insertion.
The unaffected leg is abducted as far as possible to ease image intensifi er positioning. This will also allow easier access to entry point.
Patient Positioning and Fracture Reduction
Incision
The design of the T2 Recon Nail, with a 4° medial lateral bend, will only allow for insertion through the tip of
the greater trochanter.
With experience, the tip of the greater trochanter can be identifi ed by palpation (Fig. 4).
A longitudinal skin incision of approximately 3−5cm is made starting just above the greater trochanter to the iliac crest (Fig. 5). The incision is then deepened to expose the tip of greater trochanter.
Smaller or larger incisions may be used based on individual patients anatomy and at the surgeon’s discretion.
Note:
The targeting instruments of the
T2ReconNailhavebeendesigned
to allow for a more percutaneous approach.
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The entry point is located at the junction of the anterior third and posterior two-thirds of the greater trochanter on the medial edge of the tip itself (Fig. 6).
Note:
Before opening the tip of greater trochanter, image intensifi er
views(A/PandM/L)should
be used to confi rm correct identifi cation of the entry point.
The medullary canal can be opened with the
• CurvedAwl/CurvedAwl,90°
Handle or
• OneStepConicalReamer.
Note:
Densecorticalbonemayblock
the tip of the Awl during opening of the entry portal. Inserting fi rst the optional Awl Plug into the Awl will avoid penetration of bone debris into the cannulated Awl shaft. The Awl Plug is
thenremovedforGuideWire
insertion.
• Entry point with Curved Awl
Once the tip of the greater trochanter has been opened (Fig. 7a), the Ø3 × 1000mm Ball Tip Guide Wire may be advanced through the cannulation of the Curved Awl with the Guide Wire Handle and Chuck (Fig. 7 b).
The proximal femur may then be prepared with the One Step Conical Reamer.
anterior posterior
1
/
3
2
/
3
Fig. 6
Fig. 7a
Fig. 7b
Operative Technique
Entry Point
• The Tip of the
Greater Trochanter
Fig. 7a
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Fig. 9
Fig. 8
K-Wire
Fig. 8a
Operative Technique
• Entry point with
One Step Conical Reamer
Alternatively, the 13mm diameter One Step Conical Reamer for the 9 and 11mm nails or the 15mm diameter Reamer for the 13 and 15mm nails may be used for opening the medullary canal and reaming of the trochanteric region.
Under image intensifi cation control, the entry point is made with a Ø3.2 × 400mm Recon K-Wire which is attached to the Guide Wire Handle and advanced into the medullary canal. Confi rm its placement within the center of the medullary canal on A/P and lateral image intensifi er views.
Note:
TheReconK-Wireusedforthe
entry point should not be used again for the Lag Screw insertion. It is recommended that a new
K-Wirebeutilized.
The Recon Protection Sleeve and Multi-hole Trocar are positioned with the central hole over the K-Wire.
Note:
The Multi-hole Trocar has a special design for more precise
insertionoftheØ3.2mmRecon K-Wire(Fig.8).Besidethecentral
hole, 4 other holes are located eccentrically at different distances from the center (Fig. 8a) to easily revise insertion of the guiding
K-Wireintheproperposition
(entry point).
When correct placement of the guiding Recon K-Wire is confi rmed on image intensifi er views (A/P and lateral), keep the Tissue Protection Sleeve in place and remove the Multi-hole Trocar.
The T-Handle is attached to the One Step Conical Reamer and hand reaming is performed over the Recon K-Wire through the Tissue Protection Sleeve (Fig. 9).
The Recon K-Wire is then removed and replaced with the Ø3 × 1000mm Ball Tip Guide Wire.
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The Ø 3 × 1000mm Ball Tip Guide Wire is inserted with the Guide Wire Hand le throug h the frac tu re site to the level of the epiphyseal scar.
The Ø 9mm Universal Rod with Reduction Spoon may be used as a fracture reduction tool to facilitate Guide Wire insertion through the fracture site (Fig. 10).
Note:
The Ball Tip at the end of the
GuideWirewillstoptheBixcut
reamer* head (Fig. 11).
Caution:
Prior to reaming, it is important to check the centered intramedullary position of the
GuideWirewiththeimagein-
ten sifi er. Lateral displacement
oftheGuideWirecouldleadto
resection of more bone on the lateral side of the wire, which in turn will lead to an offset position of the nail and increase the risk of a shaft fracture.
Note:
Make sure that the reduction is maintained throughout the reaming process.
Reaming is commenced in 0.5mm in crements until cortical contact occurs (Fig. 12).
For easier nail insertion, the medullary canal should be reamed at least 2mm more than the diameter of selected nail (Fig. 13).
Fig. 10
Fig. 12
Fig. 13
Fig. 11
Operative Technique
Reaming
* see pages 36-37 for additiona l Bixcut Reamer
system details
+ 2mm more than the selected nail diameter
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