enhanced stability constrained linerssynthes.vo.llnwd.net/o16/llnwmb8/int mobile/synthes...surg....
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References
1. Sanchez-Sotelo J, Haidukewych GJ, Boberg CJ. Hospital Cost of Dislocation After Primary Total Hip Arthroplasty. J Bone Joint Surg. 2006;88A:290-294.
2. Brodner W, Grübl A, Jankovsky R, Meisinger V, Lehr S, Gottsauner-Wolf FJ. Cup inclination and serum concentration of cobalt and chromium after metal-on-metal total hip arthroplasty. J Arthroplasty. 2004;19(8 Suppl 3):66-70.
3. Williams S, Leslie I, Isaac G, Jin Z, Ingham E, Fisher J. Tribology and wear of metal-on-metal hip prostheses: infl uence of cup angle and head position. J Bone Joint Surg. 2008;90A Suppl 3:111-7.
4. Udomkiat P, Dorr LD, Wan Z. Cementless hemispheric porous-coated sockets implanted with press-fi t technique without screws: average ten-year follow-up. J Bone Joint Surg. 2002;84A:1195-200.
5. Schmalzried TP, Guttmann D, Grecula M, Amstutz H. The relationship between the design, position, and articular wear of acetabular components inserted without cement and the development of pelvic osteolysis. J Bone Joint Surg. 1994;76A:677-688.
6. Kennedy JG, Rogers WB, Soffee KE, et al. Effect of acetabular component orientation on recurrent dislocation, pelvic osteolysis, polyethylene wear and component migration. J Arthroplasty 1998;13:530-534.
7. Prudhommeaux F, Hamadouche M, Nevelos J, et al. Wear of alumina-on-alumina total hip arthroplasty at a mean 11-year followup. Clin Orthop. 2000; 397:113.
8. Walter WL, O’Toole GC, Walter WK, Ellis A, Zicat BA. Squeaking in ceramic-on-ceramic hips: the importance of acetabular component orientation. J Arthroplasty. 2007;22:496-503.
9. Tower SS, Currier JH, Currier BH, Lyford KA, Van Citters DW, Mayor MB. Rim cracking of the cross-linked longevity polyethylene acetabular liner after total hip arthroplasty.J Bone Joint Surg Am. 2007 Oct;89(10):2212-7.
10. Pinnacle Constrained Liner Design History File (Project No. 452-407-013) 2006.
9068-84-052 version 3 Issued: 11/12
0086
DePuy International LtdSt Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (0)113 387 7800Fax: +44 (0)113 387 7890
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©DePuy International Ltd. and DePuy Orthopaedics, Inc. 2012. All rights reserved.
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Product Rationale & Surgical Technique
Enhanced Stability Constrained Liners
Contents
Managing Stability 3
Cup Positioning 5
Surgical Technique 6
Product Information 9
Ordering Information 10
3
The DePuy portfolio offers a continuum of products to address
hip instability. The PINNACLE® Acetabular Cup System includes:
Enhanced Stability Constrained Liners
• High strength head capture
• May be used with uni-polar or bi-polar heads
• +4 Neutral and +4 10° options
• The liners are made of GVF polyethylene
• 28, 32, 36, 40, 44 mm IDs
Managing Instability
Hip instability and dislocation are uncommon yet significant
issues with THA1. A bearing system that provides multiple
options is important in helping surgeons address and minimise
instability. The PINNACLE Acetabular Cup System offers
lateralised, face changing, lipped, large inner diameter and
constrained liners, giving surgeons the power to choose a
solution that meets each of their intraoperative needs.
Managing hip stability can be challenging, as there may be
multiple causes acting either independently or in tandem. These
include:
• Soft tissue or bony impingement
• Mechanical impingement of the prosthetic components
caused1 by suboptimal positioning
• Soft tissue laxity
Managing Cost of Dislocation
Dislocation after primary hip replacement continues to be a
prevalent procedure and usually requires the use of expensive
hospital resources or even revision surgery.1
The treatment of dislocation diminishes the cost-effectiveness
of an otherwise very successful surgical procedure and causes
substantial costs to the hospital and the society. 1
Prevention of dislocation after hip arthroplasty is critical not
only to minimise patient morbidity but also to maintain the
cost-effectiveness of this surgical procedure.1
Managing Stability
By understanding the causes of instability and the number of options available to address them within the PINNACLE system, the
goal of a more stable construct can be addressed in several ways.
It is important to understand the trade-offs associated with the various options and the appropriate indications for use.
Available in +4 neutral / +4 10°
• Lateralises head centre
• Redirects articulation of available range of motion
Chamfered titanium alloy constraining ring provides
ease of assembly and increased stability.
ARD (Anti-Rotational Device) tabs for rotational stability.
Titanium alloy locking ring securely holds the liner into
the PINNACLE cup to minimise potential disassembly.
A
B D
E
F
C
A
B
Ridge to aid in preventing constraining ring slippage.
Progressively larger ID sizes provide up to 112° range of
motion.10
E
FC
Poly slits and a flex groove for ease of head insertion.D
4
Managing Stability
5
Peer reviewed publications highlight the importance of acetabular component
positioning in relation to short and long term outcomes during total hip
arthroplasty for all types of bearing materials.2-9
Cup positioning should be varied to optimise fixation, range of motion
and dislocation resistance and minimise the likelihood of subluxation,
impingement and edge loading. This may be assessed during pre-operative
planning, acetabular preparation and cup trialling. Sub-optimal component
positioning may lead to edge loading, dislocation, increased wear, elevated
metal ion release, ceramic squeaking and polyethylene fracture.2-9
The target cup inclination (as measured on radiographs) should be 40-45°
taking into account local soft tissue and anatomic landmarks. The target
cup anteversion (as measured on radiographs) should be 15-20° taking into
account local soft tissue and anatomic landmarks.
An alignment guide is provided to assist with cup positioning; however, cup
orientation in the patient depends on patient position. The alignment guide
does not allow for variation in patient position with respect to the operating
table and it should be noted that patient orientation can vary throughout the
procedure.
Cup Positioning
Liner to shelllocking ring
Headconstraining
ring
6
Surgical Technique
Note: trials are available and should be used
prior to implanting
STEP 1
Insert the PINNACLE primary or PINNACLE revision
cup as per the PINNACLE Cup System Surgical
Technique (9068-50-050).
STEP 2
Utilise peripheral and/or dome screws as needed
to securely fix the cup in place. Irrigate and clean
the inside of the cup to ensure it is free of debris.
STEP 3
Following insertion of the final acetabular cup and
femoral component, the trial inserts can be used
in the cup to confirm insert selection and evaluate
joint stability and range of motion.
STEP 4
Seat the constrained liner into the PINNACLE cup
and align the ARD (anti-rotation device) tabs. The
pre-assembled locking ring is designed to fit into
the groove around the inner circumference of the
PINNACLE cup.
Chamfer
7
STEP 5
Utilising an impactor tip one size smaller than
the ID of the liner to be impacted, seat the
constrained liner into the cup. The top of the
ARDs should be flush with the polished face of
the PINNACLE cup.
STEP 6
Place the chamfered constraining ring over the
neck of the implant in the correct orientation. The
chamfered edge of the constraining ring should
be facing the acetabular cup.
STEP 7
With the femoral head implanted onto the stem,
reduce the femoral head and lock the constraining
ring onto the face of the constrained liner.
Note: Do not insert a trial femoral head into
the constrained liner, as it will be difficult to
remove.
Note: If deemed necessary, use the PINNACLE
ring inserter handle to facilitate the handling
of the constraining ring. Assemble the
appropriate ring inserter (size related) onto
the handle and then snap the constraining
ring into the inserter. With slight pressure,
the ring will be seated onto the constrained
liner. The curve of the handle facilitates force
application, as the curve places the handle
directly above the centre of the ring.
Surgical Technique
8
STEP 8
Verify complete assembly of the construct, and
review the range of motion to ensure appropriate
component placement was achieved.
STEP 9a
If removal of a PINNACLE constrained liner is
necessary, the use of the extractor tip will be
helpful: Assemble the extractor tip to the straight
PINNACLE impactor. The tip can be screwed onto
all available impactors of the PINNACLE system.
STEP 9b
Place the extractor tip into an empty ARD
(Anti-Rotation Device) to lever the constrained
liner out of the cup. Several attempts through
different ARDs might be necessary to enable the
release of the liner.
Surgical Technique
9
Product Information
Liner Size ID Size Dome 45˚ ROM*
28 x 48 28 9.6 8.2 89˚
28 x 50 28 10.6 9.3 89˚
32 x 52 32 9.6 8.3 96˚
32 x 54 32 10.6 9.2 96˚
36 x 56 36 9.7 8.3 104˚
36 x 58 36 10.4 9.1 104˚
36 x 60 36 11.2 9.8 104˚
40 x 62 40 9.9 8.6 109˚
Potential ROM10
Up to 112˚
Liner Size ID Size Dome 45˚ ROM*
40 x 64 40 10.6 9.3 109˚
40 x 66 40 11.4 10.1 109˚
40 x 68 40 12.2 10.8 109˚
44 x 70 44 1.2 9.8 112°
44 x 72 44 12.1 10.8 112°
44 x 74 44 13.2 11.8 112°
44 x 76 44 14.2 12.9 112°
*Range of Motion (ROM) as shown here describes a sweep angle, tested with +4 Neutral Liners and a 12/14 Taper DePuy SUMMIT® POROCOAT® Size 6High Offset Stem.10
Poly Thickness10 (mm) Poly Thickness10 (mm)
10
Ordering InformationImplants
Description
Item Number Trial Number ID OD
1218-28-648 2218-28-648 28 48
1218-28-650 2218-28-650 28 50
1218-32-652 2218-32-652 32 52
1218-32-654 2218-32-654 32 54
1218-36-656 2218-36-656 36 56
1218-36-658 2218-36-658 36 58
1218-36-660 2218-36-660 36 60
1218-40-662 2218-40-662 40 62
1218-40-664 2218-40-664 40 64
1218-40-666 2218-40-666 40 66
1218-40-668 2218-40-668 40 68
1218-44-670 2218-44-670 44 70
1218-44-672 2218-44-672 44 72
1218-44-674 2218-44-674 44 74
1218-44-676 2218-44-676 44 76
Description
Item Number Trial Number ID OD
1218-28-748 2218-28-748 28 48
1218-28-750 2218-28-750 28 50
1218-32-752 2218-32-752 32 52
1218-32-754 2218-32-754 32 54
1218-36-756 2218-36-756 36 56
1218-36-758 2218-36-758 36 58
1218-36-760 2218-36-760 36 60
1218-40-762 2218-40-762 40 62
1218-40-764 2218-40-764 40 64
1218-40-766 2218-40-766 40 66
1218-40-768 2218-40-768 40 68
1218-44-770 2218-44-770 44 70
1218-44-772 2218-44-772 44 72
1218-44-774 2218-44-774 44 74
1218-44-776 2218-44-776 44 76
+4 Neutral +4 10˚
Item Number Description*
2217-50-041 Straight Impactor
2217-50-005 26 mm Impactor Tip
2217-50-006 28 mm Impactor Tip
2217-50-007 32 mm Impactor Tip
2217-50-008 36 mm Impactor Tip
2217-50-060 40 mm Impactor Tip
*Use an impactor tip one size smaller than the ID of the liner
Instruments
Item Number Description
2218-00-020 PINNACLE Cons Ring Handle
2218-00-028 28 mm PINNACLE Cons Ring Inserter
2218-00-032 32 mm PINNACLE Cons Ring Inserter
2218-00-036 36 mm PINNACLE Cons Ring Inserter
2218-00-040 40 mm PINNACLE Cons Ring Inserter
2218-00-044 44 mm PINNACLE Cons Ring Inserter
2218-00-010 PINNACLE Liner Extractor Tip
Further sizes are available for 32 mm ID Constrained Inserts (1218-32-656 to 1218-32-676) for cup sizes up to 76 mm OD. To prevent
dislocation and maximise ROM as much as possible, the use of the largest possible head size per cup size is recommended.