Surgical Technique Polarus® 3 Solution

Transcription

Surgical Technique
Polarus® 3 Solution
Plates and Nails
Acumed® is a global leader
of innovative orthopaedic and
medical solutions.
We are dedicated to developing
products, service methods,
and approaches that improve
patient care.
Polarus® 3 Solution
Design Surgeon
Mr Christopher Michael Robinson
BM BS, B Med Sci, FRCS (Edin)
Acumed® Polarus® 3 Solution
Plates and Nails
The Acumed Polarus 3 Solution has been designed to offer plate
and nail options to treat proximal humerus fractures. The system
is comprised of instrumentation to perform both plate and nail
surgeries. While they are provided together for convenience, a
plate and nail should not be used on the same fracture. The system
introduces a number of improvements to the implants as well as
advancements in instrumentation compared to the first generation
Polarus Nail, Polarus Plus Nail, and Polarus Proximal Humerus Plate
(PHP). The information included in this surgical technique provides
the recommended procedures for implantation and removal.
2
Indications for use: The Acumed Polarus 3 Solution includes
plates, nails, screws, and accessories designed to address
fractures, fusions, and osteotomies of the humerus.
Contents
Introduction
2
Surgical Technique Overview
3
Standard and Posterior
Plate Surgical Technique
5
Proximal Nail
Surgical Technique
13
Distal Nail
Surgical Technique
21
Ordering Information
28
Notes
30
Acumed® Polarus® 3 Solution Surgical Technique
Standard and Posterior Plate Technique
1
PREOPERATIVE PLANNING
Fluoroscopy should be used in all cases. Polarus 3
Plate X-ray Templates (90-0037) are available and
should be used preoperatively to aid in implant selection.
Plate selection should be based on the fracture pattern.
Fracture patterns which include posterior greater tuberosity
fragments will likely require the Posterior Plate (7001-02XXX-S),
while less complex fracture patterns can utilize the Standard
Plate (7001-01XXX-S). The left plates are colored blue and
the right plates are colored green. Images in this surgical
technique indicate left plates only.
2
PATIENT POSITIONING
The patient is placed in a beach chair position and
the arm is draped. Create an entry site for access to
the proximal humerus through a 10 mm standard delto-pectoral
incision made obliquely, in line with the deltoid-pectoral
interval. As an alternative, a deltoid-splitting incision may be
made in a more longitudinal direction, starting at the level
of the acromioclavicular joint and extending distally. This
approach may be more cosmetic for the patient. More detail for
each approach is offered in the next section.
3
3
APPROACH AND INCISION
If posterior fixation is desired, the deltoid splitting
approach is recommended.
Deltopectoral
Deltopectoral Approach
Sharply dissect down to the level of the fascia and elevate the
skin flaps. Identify the cephalic vein and develop the interval
between the deltoid and the pectoralis. Retract the cephalic
vein laterally and the pectoralis major medially. Release the
fascia along the lateral border of the coracobrachialis and
retract it medially to expose the proximal humerus with the
subscapularis tendon attachment. To help facilitate reduction
and improve fracture visualization, release the superior
one-third of the pectoralis major from the shaft. It is important
to place a finger underneath the pectoralis major as it is
being released to protect the biceps tendon, which lies
directly underneath.
Deltoid Split
Either a bra strap (with reflection of a distally-based skin flap)
incision or a direct lateral skin incision can be used. The deltoid
is split and reflected off the acromion proximally. The axillary
nerve is identified and carefully protected. The nerve is often
located approximately 5.6 cm from the apex of the humeral
head and 6.9 cm from the acromion.1
Deltoid Split Approach
Two soft-tissue windows are created through the deltoid above
and below the area where the axillary nerve passes. The upper
window is used for fracture reduction, plate insertion and
insertion of proximal screws into the plate. The lower window is
used to ensure the plate is properly seated on the shaft of the
humerus and to allow insertion of the distal screws.
1.
4
“Surgical anatomy of the axillary nerve and its implication in the
transdeltoid approaches to the shoulder” J Shoulder Elbow Surg (2010)
19, 1166-1174
4
BONE REDUCTION
The goals of bone reduction are:
1. Reduction of any subluxation or dislocation of the
humeral head from the glenoid
2. Correction of any varus or valgus deformity of the
humeral head
3. Restoration of the normal anatomic relationship between
the head and tuberosities (if these are fractured)
4. Reduction of the humeral head to the shaft
The definitive fixation should aim to fix the humeral head to
one or both tuberosities and to secure the humeral head to the
shaft without residual subluxation or varus/valgus deformity.
This may require a combination of screws separate from the
plate, non-absorbable interosseous sutures, and locking
plate fixation.
Note: Radiolucent Carbon Fiber Retractors (80-1598 and
80-1599) are available to assist in reduction without obscuring
radiographic visibility.
Plate Lengths
4-Hole
94 mm
6-Hole
115 mm
10-Hole
155 mm
14-Hole
195 mm
18-Hole
235 mm
22-Hole
275 mm
5
PLATE SELECTION
The Polarus 3 Proximal Humerus Plates are
designed to fit an array of patient anatomies
and are left and right specific. In most cases, the Standard
Plate should be chosen. If the fracture involves the greater
tuberosity, the Posterior Plates may be a better choice. If the
fracture pattern includes a fracture line distal to the surgical
neck, a variety of plate lengths are available. To assist with
plate selection, the Polarus 3 Implant Sizer (80-1617) can be
used under fluoroscopy. The sizer can be used externally or
inserted against the periosteum.
Note: There are no plate trials. Plates are sterile packaged.
X-ray templates are available. If plates longer than 10 holes
(155 mm) are desired, Acumed provides optional plates which
need to be requested prior to the surgery.
Implant Sizer
5
6
PLATE PLACEMENT
AND REDUCTION
Select the appropriate Polarus 3 Targeting Guide,
Plate (Left: 80-1589 or Right: 80-1590) and secure it to the
plate with the Polarus 3 Plate Targeting Locking Bolt (80-1591),
utilizing the thumb grip.
If the Posterior Plate is used, Polarus 3 Plate Drill Guides,
Locking (80-1588) can be used to adjust the angle of the two
posterior tabs prior to screw placement.
Caution: Do not bend past 20°; do not bend more than once.
To prevent screw interference, screws longer than 26 mm
should not be used in these holes.
Place the plate approximately 5 mm posterior to the bicipital
groove and approximately 8–10 mm inferior to the top of the
greater tuberosity. Confirm fracture reduction and plate height
fluoroscopically. When proper reduction and positioning are
obtained, provisionally secure the plate to the bone with
2.0 mm Guide Wires (WS-2009ST), the Polarus 3 Reduction
Device (80-1601), Ball Spike Reduction Tool (80-1637), or
Polarus 3 Plate Tacks (80-1595). The reduction device should
be used in the longest oblong slot to avoid blocking access to
other screw holes. The Polarus 3 K-wire Guide (80-1600) is also
available to assist with the placement of K-wires.
Sutures may be utilized at this time to improve construct
stability. The plate features suture holes to address greater
tuberosity fragments in three and four-part fractures. The
targeting guide contains a suture cleat which can be used to
temporarily maintain tension on the suture. This should be
used with care to avoid damaging the suture integrity.
6
7
SCREW INSERTION—SHAFT
Note: The same type of screw is used in every
hole, there are no nonlocking screws. The locking
behavior of a screw is determined by the hole it is inserted
into. Round, threaded holes are locking, oblong slots are
nonlocking. Take care to remove any burrs which may have
formed during screw insertion.
To prepare the bone, use the Polarus 3 Plate Drill Guide,
Drop-In (80-1587) and the Polarus 3 2.8 mm Surgibit® Short Drill
(80-1592), using the laser band to determine the appropriate
length of screw. Screw depth can also be measured with the
Polarus 3 Depth Gauge (80-1776).
Using the T15 Stick-Fit Hexalobe Driver (80-0760) insert a
4.3 mm Low-profile Hexalobe Screw (3011-430XX-S) of the
appropriate length. The screw may be inserted through any
oblong slot in the plate distal to the fracture. Ensure that the
screw is fully seated into the plate. The second slot is the
longest and will allow for the most adjustment.
The provisional fixation hardware may now be removed.
Note: Oblong slots do not provide the option to lock screws to
the plate. Screws lengths of 20–32 mm are commonly used in
the shaft. If dense bone is encountered, the Polarus 3 4.3 mm
Screw Tap (80-1623) and Polarus 3 Tap Sleeve (80-1593) may
be used to further prepare the bone for screw insertion.
Locking Holes
Nonlocking Slots
7
8
SCREW PREPARATION—
HUMERAL HEAD
Please use the diagram for the suggested
order of screw insertion. The first proximal screw placed
should be the anterior screw second from the top
(see image, #1) on the plate. Utilizing a Polarus 3 2.8 mm Short
Drill (Sharp: 80-1592 or Blunt: 80-1597), prepare the bone for
screw insertion. Both a traditional sharp drill and a blunt-tipped
drill are available. The blunt drill can be used to help avoid
perforation of the joint surface at the far cortex. Care should be
taken not to over-drill with either drill. Drill the hole and utilize
the laser mark on the drill with the scale on the back of the
drop-in plate drill guide to determine the appropriate screw
length. Screw depth can also be measured with the depth
gauge through the targeting guide.
For accurate determination, be sure that the drill guide is fully
seated into the targeting guide. The Locking Drill Guide is
also available, but requires a second measurement step using
the depth gauge, through the targeting guide. Using the T15
hexalobe driver, insert a low-profile hexalobe screw of the
appropriate length.
Note: Use of fluoroscopy will help confirm accurate
screw placement in the humeral head. Prior to inserting locking
screws, be sure to confirm that the fracture is
reduced anatomically.
2
Standard Plate
3
1
For the Standard Plate, the remaining proximal screws
should be inserted in a clockwise order except for the hole
occupied by the locking bolt. This hole (#8) can be drilled
through the bolt but the targeting guide must be removed
before using the depth gauge to determine the appropriate
length of screw.
4
7
5
8
6
Posterior Plate
Suggested Standard Plate Screw Insertion Order
2
3
1
4
7
5
8
9
10
6
For the Posterior Plate, the remaining proximal screws should
be inserted in a clockwise order except for the tabs and the
hole occupied by the locking bolt. This hole (#8) can be drilled
through the bolt but the targeting guide must be removed
before using the depth gauge to determine the appropriate
length of screw. The tabs should be the last screws inserted,
and screws longer than 26 mm should not be used to avoid
screw interference.
If the Posterior Plate is used, a locking drill guide can be
used to adjust the angle of the two posterior tabs prior to
screw placement.
Caution: Do not bend past 20°; do not bend more than once.
8
Suggested Posterior Plate Screw Insertion Order
After all proximal screws are inserted, remove the targeting
guide and ensure that all screw heads are fully seated into the
plate. If sutures are used with the targeting guide cleat, refer to
Step 10 of the technique prior to removing the targeting guide.
If any screws have trouble locking into the plate, remove
them and use the Polarus 3 Targeting Awl (80-1620) to further
prepare the entry site.
9
ADDITIONAL SHAFT
SCREW INSERTION
For the remaining shaft holes, insert a 4.3 mm
screw to secure the plate to the shaft. For locking fixation
use round holes. For nonlocking fixation, the screw may be
inserted through any oblong slot in the plate.
Use the Drop-In Plate Drill Guide and the 2.8 mm Surgibit®
Short Drill; using the Polarus 3 Depth Gauge (80-1776) to
determine the appropriate length of screw to be used.
Using the T15 hexalobe driver, insert a screw of the
appropriate length.
Note: If dense bone is encountered, a 4.3 mm screw tap and
tap sleeve may be used to further prepare the hole.
9
10
SUTURES
Remove sutures from targeting guide and
remove the targeting guide from the plate.
Secure sutures to the plate by passing them through the suture
holes on the edges of the plate.
Optional: Plate tabs may also be used as suture holes.
11
SOFT-TISSUE CLOSURE
Layered closure is performed using heavy
absorbable sutures. In the deltoid-splitting
approach meticulous repair of the deltoid split is important to
avoid deltoid dehiscence. Direct transosseous suturing of the
deltoid to the acromion is recommended. Close the wound in
layers with a subcuticular stitch.
12
POSTOPERATIVE PROTOCOL
Passive range of motion exercises are
initiated for the first four weeks, then
active assisted for two weeks. Active range of motion
and strengthening are started at approximately six weeks
postoperatively. Clinical and radiological monitoring should
continue until a satisfactory functional outcome and fracture
union have been achieved.
Implant Removal
If removal of the implant is desired, prepare the exposure as
in Step 3. Locate the screws and remove them with the T15
hexalobe driver, then remove the plate. If Acumed drivers are
unavailable, the hexalobe screws may be removed with a T15
hexalobe connection. The Acumed Screw Removal System can
also assist removal.
10
Proximal Nail Surgical Technique
1
Nail X-ray Templates (90-0038) are available and
should be used preoperatively to aid in implant selection. The
proximal nails are left and right specific.
2
PATIENT POSITIONING AND
SURGICAL EXPOSURE
The patient may be placed either supine or in a
beach chair position so that fluoroscopy can be used to allow
intraoperative assessments of fracture reduction, implant
insertion, and a thorough evaluation of the final implant
position. A radiolucent table is recommended to facilitate
fluoroscopy. Position the shoulder off the edge of the table
or, alternatively, a bolster can be placed beneath the scapula
to elevate the shoulder. Ensure there is enough clearance
to externally rotate the humerus without the screw targeting
guide contacting the table during later steps.
For an anterolateral approach, a 3–5 cm incision is made at
the anterolateral aspect of the acromion extending parallel to
the fibers of the deltoid. The supraspinatus tendon is then split
in the direction of the fibers to expose the proximal humerus
posterior to the biceps tendon. It is important not to detach the
insertion of the tendon. A Rotator Cuff Retractor (80-1822) is
available to assist with exposure.
3
FRACTURE REDUCTION
The goals of fracture reduction are:
1. Reduction of any subluxation or dislocation of the
humeral head from the glenoid
2. Correction of any varus or valgus deformity of the
humeral head
3. Restoration of the normal anatomic relationship between
the head and tuberosities (if these are fractured)
4. Reduction of the humeral head to the shaft
The definitive fixation should aim to fix the humeral head to
one or both tuberosities and to secure the humeral head to the
shaft without residual subluxation or varus/valgus deformity.
This may require a combination of screws separate from
the nail, non-absorbable interosseous sutures, and locking
nail fixation.
11
4
GUIDE WIRE INSERTION
The implant insertion point is located approximately
10 mm posterior to the bicipital groove, medial to
the greater tuberosity. For three-part fractures, care should be
taken to make the starting point at the junction of the articular
surface and the greater tuberosity.
Assemble the Polarus 3 Guide Wire “T” Handle (80-1734) and
the Polarus 3 Locking Knob (80-1633) onto the Polarus 3 Guide
Wire, 20" Trocar Tip (35-0009) as shown to the left, paying
particular attention to the orientation of the depth markings
along the length of the wire.
The trocar tip guide wire can be advanced into the canal
as a guide for subsequent steps. The tip of the Polarus 3
Cannulated Awl (80-1551) should be carefully buried over the
guide wire no deeper than 30 mm below the bone surface to
create an entry hole 10 mm in diameter. The groove on the
awl is approximately 50 mm from the tip. If the fracture runs
through the insertion site, it may be necessary to create a
starting hole with a burr or rongeur.
Optional: An optional technique is to perforate the cortex with
a 2.8 mm drill and then pass the Polarus 3 Guide Wire, 20"
Blunt (35-0008) down into the canal.
The guide wire position should be verified with images in
both the A/P and oblique planes to ensure that the guide wire
is inside the humerus and in the canal. Fluoroscopy can be
utilized to ensure that the guide wire has not exited through
the fracture site.
Note: A drill bit or K-wire may also be used in the
proximal fragment as a joystick to aid fracture reduction
and realignment. The drill should be positioned to avoid
interference with both the nail and targeting guide
during insertion.
12
5
CANAL PREPARATION
The entry site is then prepared using the 10 mm
bud drill over the guide wire. Drill with the 10 mm
Bud Drill to a depth of approximately 50–60 mm to allow the
nail to pass into the canal. An alternate technique for preparing
the canal is to use the Polarus 3 Cannulated Broach (80-1553).
Insert the broach to the level of the last cutting tooth. The
lateral side of the broach is designated by the direction of the
broach handle. After the bud drill is used, the Polarus 3 Guide
Wire Passer (80-1555) is available to assist in passing the guide
wire past the fracture site.
6
ASSEMBLE THE TARGETING GUIDE
1) Attach the Polarus 3 Nail Targeting Connector
(80-1629) to the appropriate Proximal Targeting
Guide (Left: 80-1626 or Right: 80-1627), securing with a Locking
Knob (80-1633).
2) Insert the Locking Bolt (80-1625) through the barrel of the
targeting connector.
Note: When removing implant from sterile packaging, take
care not to disengage PEEK insert from head of nail. The insert
should be visible through the slot in the nail prior to insertion.
1
2
3
4
3) Make sure the internal PEEK sleeve is still fully seated in
the head of the nail prior to attaching the targeting guide.
Assemble implant onto the targeting connector, aligning the
reference marks on the implant and targeting connector.
Note: The slot on the implant is offset to prevent misalignment.
4) Tighten the bolt into position with the provided Locking Bolt
Finger Wrench (MS-0611).
When assembled properly, the nail should curve toward the
targeting guide.
13
7
IMPLANT INSERTION
Insert the nail over the guide wire. Verify that the
proximal end of the nail is at least 5 mm below the
cortex to avoid impingement. The nail should be inserted
with hand pressure. Once proper depth is achieved, the nail
and targeting guide may be rotated up to 20° to both align
the screws with the bone fragments and to avoid the biceps
tendon. To avoid injury to the axillary nerve, do not insert the
nail more than 10 mm deep relative to the cortex. If a good
A/P image of the humeral head is viewed, the forearm can be
locked at approximately 30° of external rotation. Using a K-wire
in the hole marked “30° retroversion” in the targeting guide will
indicate this angle.
Note: Marks on the barrel of the targeting connector are a
reference for the surgeon that the nail is either 5 mm or 10 mm
below the cortex. The depth of the nail may also be verified
by inserting a 2.0 mm Guide Wire (WS-2009ST) through the
small hole located below the knob on the targeting guide.
Under fluoroscopy, the wire will point to the top of the nail. It is
important that the C-arm is exactly parallel to the arm to obtain
an accurate image of implant depth.
Note: Remove the guide wire prior to drilling.
8
PROXIMAL SCREW PLACEMENT
Note: The same type of screw is used in every
hole, there are no nonlocking screws. The locking
behavior of a screw is determined by the hole it is inserted
into. The proximal PEEK insert will create locking friction as
the screw threads into it. Small burrs may form during screw
insertion into PEEK, but these should remain contained inside
the nail.
4.3 mm Low-profile Hexalobe Screws (3011-430XX-S) are
inserted proximally utilizing the Polarus 3 Cannula, Ratcheting
(80-1619), Polarus 3 Targeting Awl (80-1620), and Polarus 3 Drill
Guide, Nail (80-1621).
Note: The cannula will lock into the targeting guide when the
arrow and flat are facing up. This locking action can be used
to assist with reduction of the fracture and to hold fragments
reduced. To unlock the cannula, turn it a quarter-turn to the left
or right.
Important: Remove the guide wire prior to drilling.
14
The diagram on the following page shows the suggested
order of screw insertion. Starting with the most anterior screw
position, insert the cannula and targeting awl through the
targeting guide and through a stab incision over the target site.
Lightly tap the awl with the Multiple Contact Hammer (80-1538)
to create a small indentation in the bone to assist with targeting
accuracy. Only light tapping should be used on the awl to avoid
splitting the cortex.
Remove the awl and insert the drill guide through the cannula
and up to the bone surface. The drill guide should be flush to
the surface. Before drilling, be sure the guide wire is removed.
Utilizing a Polarus 3 2.8 mm Long Drill (Sharp: 80-1624 or
Blunt: 80-1634), prepare the bone for screw insertion. Both a
traditional sharp drill and a blunt-tipped drill are available. The
blunt drill can be used to help avoid perforation of the joint
surface at the far cortex. Care should be taken not to over-drill
with either drill. Use the laser mark on the drill with the scale on
the back of the drill guide to determine the appropriate screw
length. If the screw size reading is between sizes, round down
to the shorter size.
Prior to inserting the screw, remove the drill guide. Using the
Polarus 3 Long T15 Hexalobe Driver (80-1618) insert a 4.3 mm
screw of the appropriate length. The insertion torque of the
screw into the nail may increase as the screw engages the
internal locking sleeve of the nail. This resistance will lock the
screw into position. When the groove on the driver shaft aligns
with the end of the cannula, the screw head is approaching the
bone. Care should be taken not to advance screws into the
articular surface.
Repeat these steps to install additional locking
proximal screws.
At the surgeon’s discretion, Polarus 3 8 mm Washer, Locking
(7001-03001-S) is available for use. The Polarus 3 Washer
Cannula (80-1792) is required to insert a washer and this
cannula will not lock like the ratcheting cannula.
1
2
3
4
5
Suggested Screw Insertion Order (Left Nail Shown)
1
2
3
4
5
Suggested Screw Insertion Order (Right Nail Shown)
15
9
TARGET DISTAL SCREWS
Note: It is important to lock the distal humerus
in the correct amount of retroversion relative
to the humeral head. The fragments can be rotated under
fluoroscopy until the fragments are restored to their anatomical
positioning. If a good A/P image of the humeral head is viewed,
the forearm can be locked at approximately 30° of external
rotation. Using a K-wire in the hole marked “30° retroversion” in
the targeting guide will indicate this angle.
Insert the cannula and targeting awl into the most distal hole
in the targeting guide. Lightly tap the awl against the bone
to create a dimple. The drill guide is then inserted through
the cannula. Using the long drill, drill through both cortices.
Leaving this “placeholder” drill engaged will help to preserve
the positioning of the distal fragment. Place another cannula
into the other distal hole and dimple the bone with the awl. Use
a second drill to drill through both cortices.
Note: The distal holes are angled relative to the bone by 15° to
provide multiplanar fixation.
10
INSERT DISTAL SCREWS
Remove the more proximal drill, then,
following the above technique, insert a
screw into the most proximal of the distal holes. The Polarus 3
4.3 mm Screw Tap (80-1623) is available if dense bone is
encountered. Verify the screw position under fluoroscopy. The
screw should not extend past the medial cortex by more
than 1 mm.
Remove the “placeholder” drill from the distal hole and insert
the second screw.
16
11
INSERT CAP SCREW
Select an appropriate length Cap Screw
(4004-1000X-S).
Place the Cap Screw onto the Polarus 3 Cap Screw Driver
(80-1635) and insert into the top of the nail. The nose of the
Cap Screw driver will align the screw with the head of the
nail. Advance the cap until it is fully seated flush with the
top of the nail. The 0 mm cap screw will be fully threaded
into the nail when properly inserted, do not over-torque this
screw. Additional length cap screws are available to place
the proximal part of the construct flush to the bone surface if
desired. Never leave the construct proud of the proximal bone.
12
REPAIR ROTATOR CUFF
It is important to close the rotator cuff after
insertion of the nail. A permanent suture
such as Number 2 Ethibond may be utilized to close the rotator
cuff. Generally, two figure-8 sutures are used to close the small
longitudinal incision of the rotator cuff. After this the deltoid
is closed. The wound is then closed in layers with the deltoid
closed with Number One Vicryl or similar absorbable suture
and the skin is closed in standard fashion.
17
13
Postoperatively, the patient is placed in an
arm sling and a pain pump may be placed
in the subacromial space to help with postoperative pain relief.
The patient is started on pendulum motion exercises at one
to two weeks, a passive motion program for two to six weeks,
and active strengthening at six weeks when evident signs of
healing are seen.
Implant Removal
If removal of the implant is desired, prepare the exposure as in
Step 2. Locate the screws under fluoroscopy and remove only
the proximal screws with the T15 hexalobe driver. If Acumed
drivers are unavailable, the hexalobe screws may be removed
with a T15 hexalobe connection. Use the tip of the Polarus 3
Removal Instrument (80-1546) to remove any ingrown tissue in
the head of the nail. Remove the cap screw using the Polarus 3
Cap Screw Driver (80-1635). Thread the removal instrument
into the nail. The threaded portion of the removal tool has
cutting flutes that will remove tissue as it is inserted. The tip will
fit into the cannulation to prevent cross threading. The removal
instrument will not point straight down the humeral shaft, but
will angle laterally about 4°.
Caution: Locate and remove the distal screws before using
the multiple contact hammer. Failure to do so could result in
breaking the screws, nail, or removal instrument.
After verifying that the distal screws have been removed, slip
the forked end of the hammer over the shaft of the removal
instrument and break the nail loose with short, sharp blows.
The hammer has two sides, one of which has a 20° offset.
18
Distal Nail Surgical Technique
1
Nail X-ray Template (90-0038) are available and
should be used preoperatively to aid in implant selection. The
nail length should be chosen so that the distal holes
are distal to the fracture line and do not obstruct the radial
nerve. The Polarus 3 Distal Nails (200–280 mm) are not left or
right specific.
2
PATIENT POSITIONING AND
SURGICAL EXPOSURE
The patient may be placed either supine or in a
beach chair position so that fluoroscopy can be used to allow
intraoperative assessments of fracture reduction, implant
insertion, and a thorough evaluation of the final implant
position. A radiolucent table is recommended to facilitate
fluoroscopy. Position the shoulder off the edge of the table
or, alternatively, a bolster can be placed beneath the scapula
to elevate the shoulder. Ensure there is enough clearance
to externally rotate the humerus without the screw targeting
guide contacting the table during later steps.
For an anterolateral approach, a 3–5 cm incision is made at
the anterolateral aspect of the acromion extending parallel to
the fibers of the deltoid. The supraspinatus tendon is then split
in the direction of the fibers to expose the proximal humerus
posterior to the biceps tendon. It is important not to detach the
insertion of the tendon. A Rotator Cuff Retractor (80-1822) is
available to assist with exposure.
19
3
GUIDE WIRE INSERTION
The implant insertion point is located approximately
10 mm posterior to the bicipital groove, just medial
to the greater tuberosity. For three-part fractures, care should
be taken to make the starting point at the junction of the
articular surface and the greater tuberosity.
Assemble the Polarus 3 Guide Wire “T” Handle (80-1734) and
the Polarus 3 Locking Knob (80-1633) onto the Polarus 3 Guide
Wire, 20" Trocar Tip (35-0009) as shown to the left (see image),
paying particular attention to the orientation of the depth
markings along the length of the wire.
The trocar tip guide wire can be advanced into the canal
as a guide for subsequent steps. The tip of the Polarus 3
Cannulated Awl (80-1551) should be carefully buried over the
guide wire no deeper than 30 mm below the bone surface to
create an entry hole 10 mm in diameter. The groove on the
awl is approximately 50 mm from the tip. If the fracture runs
through the insertion site, it may be necessary to create a
starting hole with a burr or rongeur.
Optional: An optional technique is to perforate the cortex with
a 2.8 mm drill and then pass the Polarus 3 Guide Wire, 20"
Blunt (35-0008) down into the canal.
The guide wire position should be verified with images in
both the A/P and oblique planes to ensure that the guide wire
is inside the humerus and in the canal. Fluoroscopy can be
utilized to ensure that the guide wire has not exited through
the fracture site.
Note: A drill bit may also be used in the proximal fragment as
a joystick to aid fracture reduction and realignment. The drill
should be positioned to avoid interference with both the nail
and targeting guide during insertion.
20
4
CANAL PREPARATION
The entry site is then prepared using the 10 mm
bud drill over the guide wire. Drill with the 10 mm
Bud Drill to a depth of approximately 50–60 mm to allow the
nail to pass into the canal. An alternate technique for preparing
the canal is to use the Polarus 3 Cannulated Broach (80-1553).
Insert the broach to the level of the last cutting tooth. The
lateral side of the broach is designated by the direction of the
broach handle. After the bud drill is used, the Polarus 3 Guide
Wire Passer (80-1555) is available to assist in passing the guide
wire past the fracture site.
Flexible reamers are available for distal canal preparation.
These should be used sequentially over the guide wire starting
with the 8 mm size. The distal diameter of the 200–280 mm
Polarus 3 Nails is 8 mm.
5
ASSEMBLE THE TARGETING GUIDE
Attach the Polarus 3 Nail Targeting Connector
(80-1629) to the Polarus 3 Proximal Targeting Guide
(80-1628), securing with a Polarus 3 Locking Knob (80-1633).
Insert the Locking Bolt (80-1625) through the barrel of the
Targeting Connector (80-1629).
Note: When removing implant from sterile packaging, take
care not to disengage PEEK insert from the head of the nail.
Make sure the internal PEEK sleeve is still fully seated in
the head of the nail prior to attaching the targeting guide.
Assemble implant onto the targeting connector, aligning the
reference mark on the implant and targeting connector.
Note: The slot on the implant is offset to prevent misalignment.
When assembled properly, the nail will curve toward the
targeting guide.
Tighten the bolt into position with the provided Locking Bolt
Finger Wrench (MS-0611).
21
6
IMPLANT INSERTION
Insert the nail over the guide wire. Verify that the
proximal end of the nail is at least 5 mm below
the cortex to avoid impingement. The nail should be inserted
with hand pressure. Once proper depth is achieved, the nail
and targeting guide may be rotated up to 20° to both align
the screws with the bone fragments and to avoid the biceps
tendon. To avoid injury to the axillary nerve, do not insert the
nail more than 10 mm deep relative to the cortex.
Note: Marks on the barrel of the targeting connector are a
reference for the surgeon that the nail is either 5 mm or 10 mm
below the cortex. The depth of the nail may also be verified by
inserting a 2.0 mm Guide Wire (WS-2009ST) through the small
hole located just above the center hole on the targeting guide.
Under fluoroscopy, the wire will point to the top of the nail. It is
important that the C-arm is exactly parallel to the arm to obtain
an accurate image of implant depth.
Note: Remove the guide wire prior to drilling.
4.3 mm Low-profile Hexalobe Screws (3011-430XX-S) are
inserted proximally utilizing the Polarus 3 Cannula, Ratcheting
(80-1619), Polarus 3 Targeting Awl (80-1620) and Polarus 3 Drill
Guide, Nail (80-1621).
Note: The cannula will lock into the targeting guide when the
arrow and flat are facing up. This locking action can be used
to assist with reduction of the fracture and to hold fragments
reduced. To unlock the cannula, turn it a quarter-turn to the left
or right.
The diagram on the following page shows the recommended
order of screw insertion. Starting with the most anterior screw
position, insert the cannula and targeting awl through the
targeting guide and through a stab incision over the target site.
Lightly tap the awl with the Multiple Contact Hammer (80-1538)
to create a small indentation in the bone to assist with targeting
accuracy. Only light tapping should be used on the awl to avoid
splitting the cortex.
Remove the awl and insert the drill guide through the
cannula and up to the bone surface. The drill guide should
be flush to the surface. Before drilling, be sure the guide
wire is removed. Utilizing the Polarus 3 2.8 mm Long Drill
(Sharp: 80-1624 or Blunt: 80-1634), prepare the bone for screw
insertion. Both a traditional sharp drill and a blunt-tipped
drill are available. The blunt drill can be used to help avoid
perforation of the joint surface at the far cortex. Care should
be taken not to over-drill with either drill. Use the laser mark
on the drill with the scale on the back of the drill guide to
determine the appropriate screw length. If the screw size
reading is between sizes, round down to the shorter size.
22
Prior to inserting the screw, remove the drill guide. Using the
Polarus 3 Long T15 Hexalobe Driver (80-1618) insert a 4.3 mm
Screw of the appropriate length. The insertion torque of the
screw into the nail may increase as the screw engages the
internal locking sleeve of the nail. This resistance will lock the
screw into position. When the groove on the driver shaft aligns
with the end of the cannula, the screw head is approaching
the bone.
2
3
1
5
4
Repeat these steps to install additional locking proximal
screws, following the recommended order shown.
At the surgeon’s discretion, Polarus 3 8 mm Washer, Locking
(7001-03001-S) is available for use. The Polarus 3 Washer
Cannula (80-1792) is required to insert a washer and this
cannula will not lock like the ratcheting cannula.
Screw Insertion Order (Left Shoulder Shown)
2
1
3
4
7
5
Screw Insertion Order (Right Shoulder Shown)
FREEHAND TARGETING OF THE
DISTAL SCREWS
In order to target either the M/L or A/P distal screws,
locate the distal screw hole utilizing fluoroscopy. Care should
be taken to avoid damaging the radial nerve when making
the incision for the distal interlocking screws when the M/L
approach is used. Careful spreading of tissue and retraction
down to the bone will minimize injury to the nerve and improve
visibility of the screw insertion site. Using a C-arm and the
Freehand Targeting Guide (MS-0210), find the bottom of the
most distal slot. Stand up the Freehand Guide and tap it to
create a starting dimple. Place the Polarus 3 2.8mm Surgibit®
Short Drill (80-1592), and Polarus 3 Plate Drill Guide, Drop-In
(80-1587) into the dimple and drill parallel with the C-arm beam.
Leaving this “placeholder” drill engaged will help to preserve
the positioning of the distal fragment during compression.
Leaving the drill in the bottom of the distal slot, apply manual
compression if necessary.
23
8
INSERT DISTAL SCREWS
While maintaining compression, Use the C-arm and
the freehand targeting guide to find the second
distal hole. Use the drill guide and drill through both cortices as
in Step 7.
Remove the more proximal drill, then, following the above
technique, insert a screw into the most proximal of the distal
holes. The Polarus 3 4.3 mm Screw Tap (80-1623) is available
if dense bone is encountered. Verify the screw position under
fluoroscopy. The screw should not extend past the medial
cortex by more than 1 mm.
Remove the “placeholder” drill from the distal slot and use the
drill guide to determine screw length. Install the appropriate
screw length as before.
A/P Plane
M/L Plane
9
INSERT CAP SCREW
Select an appropriate length Cap Screw
(4004-1000X-S).
Place the Cap Screw onto the Polarus 3 Cap Screw Driver
(80-1635) and insert into the top of the nail. The nose of the
Cap Screw driver will align the screw with the head of the nail.
Advance the cap until it is fully seated flush with the top of the
nail. The 0 mm cap screw will be fully threaded into the nail
when properly inserted.
10
REPAIR ROTATOR CUFF
It is important to close the rotator cuff after
insertion of the nail. A permanent suture
such as Number 2 Ethibond may be utilized to close the rotator
cuff. Generally, two figure-8 sutures are used to close the small
longitudinal incision of the rotator cuff. After this the deltoid
is closed. The wound is then closed in layers with the deltoid
closed with Number One Vicryl or similar absorbable suture
and the skin is closed in standard fashion.
24
11
Postoperatively, the patient is placed in an
arm sling and a pain pump may be placed in
the subacromial space to help with postoperative pain relief.
The patient is started on pendulum motion exercises at one
to two weeks, a passive motion program for two to six weeks,
and active strengthening at six weeks when evident signs of
healing are seen.
Implant Removal
If removal of the implant is desired, prepare the exposure as in
Step 2. Locate the screws under fluoroscopy and remove only
the proximal screws with the T15 hexalobe driver. If Acumed
drivers are unavailable, the hexalobe screws may be removed
with a T15 hexalobe connection.
Use the tip of the Polarus 3 Removal Instrument (80-1546)
to remove any ingrown tissue in the head of the nail.
Remove the cap screw using the Polarus 3 Cap Screw Driver
(80-1635). Thread the removal instrument into the nail. The
threaded portion of the removal instrument has cutting flutes
that will remove tissue as it is inserted. The tip will fit into
the cannulation to prevent cross threading. The removal
instrument will not point straight down the humeral shaft, but
will angle laterally about 4°.
Caution: Locate and remove the distal screws before using
the multiple contact hammer. Failure to do so could result in
breaking the screws, nail, or removal instrument.
After verifying that the distal screws have been removed, slip
the forked end of the hammer over the shaft of the removal
tool and break the nail loose with short, sharp blows. The
hammer has two sides, one of which has a 20° offset.
25
Ordering Information
Polarus® 3 Standard Plates
Polarus® 3 Proximal Nails
Polarus® 3 Standard Plate 4-hole L
7001-0104L-S
Polarus® 3 Proximal Locking Nail 150 mm L
4001-1015L-S
Polarus® 3 Standard Plate 4-hole R
7001-0104R-S
Polarus® 3 Proximal Locking Nail 150 mm R
4001-1015R-S
7001-0106L-S
7001-0106R-S
7001-0110L-S
Polarus® 3 Locking Nail 200 mm
4002-10200-S
7001-0110R-S
4002-10220-S
7001-0114L-S
4002-10240-S
7001-0114R-S
4002-10260-S
7001-0118L-S
4002-10280-S
7001-0118R-S
7001-0122L-S
Polarus® 3 Cap Screws and Washers
7001-0122R-S
Polarus® 3 Cap Screw 0 mm
4004-10000-S
4004-10002-S
4004-10004-S
4004-10006-S
Polarus® 3 Posterior Plates
Polarus® 3 Distal Nails
Polarus® 3 Posterior Plate 4-hole L
7001-0204L-S
Polarus® 3 Posterior Plate 4-hole R
7001-0204R-S
Polarus® 3 8 mm Washer, Locking
Polarus® 3 Posterior Plate 6-hole L
7001-0206L-S
Polarus® 3 Posterior Plate 6-hole R
7001-0206R-S
Polarus® 3 Instruments
Polarus® 3 Guide Wire, 20" Blunt
35-0008
Polarus® 3 Guide Wire, 20" Trocar Tip
35-0009
Polarus® 3 2.8 mm Surgibit® Short Drill
80-1592
Polarus® 3 Plate Tack
80-1595
Polarus® 3 2.8 mm Blunt Short Drill
80-1597
Polarus® 3 2.8 mm Surgibit® Long Drill
80-1624
Polarus® 3 2.8 mm Blunt Long Drill
80-1634
2.0 mm X 9" ST Guide Wire
26
7001-03001-S
WS-2009ST
4.3 mm Low-Profile Hexalobe Screws
4.3 mm x 18 mm Low-Profile Hexalobe Screw
3011-43018-S
3011-43020-S
3011-43022-S
3011-43024-S
3011-43026-S
3011-43028-S
3011-43030-S
3011-43032-S
3011-43034-S
3011-43036-S
3011-43038-S
3011-43040-S
3011-43042-S
3011-43044-S
3011-43046-S
3011-43048-S
3011-43050-S
3011-43052-S
3011-43054-S
3011-43056-S
3011-43058-S
3011-43060-S
3011-43062-S
3011-43064-S
To learn more about the full line of Acumed® innovative
surgical solutions, please contact your local Acumed®
Sales Representative, call 888.627.9957, or
visit acumed.net.
27
SHD10-06-B
Effective: 04/2014
© 2014 Acumed® LLC
Acumed® Headquarters
5885 NW Cornelius Pass Road
Hillsboro, OR 97124
Office: 888.627.9957
Fax: 503.520.9618
acumed.net
These materials contain information
about products that may or may not be
available in any particular country or may
be available under different trademarks
in different countries. The products may
be approved or cleared by governmental
regulatory organizations for sale or use
with different indications or restrictions
in different countries. Products may not
be approved for use in all countries.
Nothing contained on these materials
should be construed as a promotion
or solicitation for any product or for the
use of any product in a particular way
which is not authorized under the laws
and regulations of the country where
the reader is located. Specific questions
physicians may have about the availability
and use of the products described on
these materials should be directed to
their particular local sales representative.
Specific questions patients may have
about the use of the products described
in these materials or the appropriateness
for their own conditions should be
directed to their own physician.
Polarus®, and Acumed® are registered
trademarks of Acumed, LLC.
Surgibit® is a registered trademark of
Surgibit IP Holding PTY Limited.

Surgical Technique Polarus® 3 Solution

Transcription

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