CORIN OPS Installation guide

Product overview and
surgical technique

50
40
30
20
10
0
-10
-20 0 20 40 60 80
Cup inclination (°)
Cup anteversion (°)
Safe zone?
Safe zones
There have been various attempts to define a ‘safe
zone’ for the orientation of an acetabular cup, and
increasing evidence to suggest that one generic
zone is not applicable5,6,7,8,9.
Pelvic tilt
Pelvic tilt is an important consideration for
a patient's physiological profile, and the arc of
pelvic motion in some patients can be as mobile
as 70° and in others as stiff as 5° during functional
activities1,10. This can have significant impact on the
functional orientation of the acetabular cup.
What is the optimal cup orientation for an
individual patient?
OPS™ is a state-of-the-art technology platform that
delivers potential target orientations unique for each
individual. These target orientations are calculated
from a dynamic pre-operative functional simulation,
which accounts for the patient's physiological profile
throughout a range of daily activities.
Clinical issue
Clinical solution
Overview
Every patient moves differently1and their total hip
replacement should be optimised to account for this.
The orientation of the acetabular cup is one of the
most important factors under the surgeon's control2,
and acetabular cup orientation has a significant
effect on device performance, including patient
outcomes, impingement, edge loading, bearing
wear, osteolysis and loosening3,4.
There remains two key issues with THR today:
What is the target for a well orientated cup?
Are we able to achieve that orientation?
1
2
1 Implant orientation
Figure demonstrating the variation in pelvic tilt (anterior red, posterior
blue) for 100 patients throughout a range of daily activities. The variance
observed can be greater than 70°.
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
Patient number
30
20
10
0
-10
-20
-30
Degrees
Get the full picture. Scan to view
the OPS™ introductory video.
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Intra-operative tools
It is inherently difficult to position the cup
during surgery and achieving a target
position is a considerable challenge in THR.
It has been shown that up to 50% of
surgeries miss the intended orientation11
and the chance of hitting a target to within
5° can be as low as 21.5%12.
Clinical issue
How is the optimised position delivered during surgery?
Once the target orientation for a specific patient has
been decided, a unique guide is produced for the
individual. The planned orientation is built into the axis
of the guide which is used intra-operatively with a
simple laser system to allow the surgeon to deliver on
the planned cup orientation.
The following surgical technique outlines this procedure.
Clinical solution
2 Delivery
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Optimizing your practice
The Corin OPS™ is a state-of-the-art
pre-operative planning technology
and delivery system, designed to
enable you to deliver on an optimised
acetabular cup position for each of
your patients.
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Cup inclination (°)
Cup anteversion (°)
Safe zone
Functional safe zone
Every patient moves differently, and the amount of pelvic tilt through functional activities should be accounted for
with total hip replacement1. OPS™ is designed to optimally orientate a cup within a safe zone, and for the cup to
remain within that safe zone as the pelvis rotates throughout functional activity.
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Operative technique
1. Laser canister assembly
The laser is inserted into the lower housing and the
cap is screwed on securely. The laser should now
be permanently on, and the laser dot should be
visible across the theatre with the naked eye.
Please consult the laser unit safety
instructions for the correct handling protocol.
2. Pelvic construct preparation
Assemble the pelvic screw onto the T-handle
inserter and place either around the acetabulum
within the incision or percutaneously in the iliac
crest. Ensure the screw is rigidly fixed into bone.
3. Assessment of guide and model
Screw the bolt into the guide and tighten with the hex
handle driver, then place the guide into the acetabular
model. There are five reference markings on the
acetabular model to assist with locating the guide.
a. The transverse plane is marked on the back of the
acetabular model
b. The identification of where the guide arms will sit
c. A projection of the rim of the acetabular component at
the planned orientation
d. A reference line along the top of the fossa which is
parallel to the transverse plane
e. A reference line perpendicular to d
For further visual confirmation refer to the electronic report.
b
c
e
d
a
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4. Acetabular preparation
Remove the fat pad and remnants of the
ligamentum teres from the acetabular fossa. Ensure
the thin layer of cartilage is removed from the fossa
lip. Identify where the arms of the guide will sit within
the acetabulum and ensure all cartilage has been
removed from these areas.
5. Guide insertion
Place the guide assembly into the acetabulum using
the guide holding forceps and apply a superomedial
pressure to ensure it is rigidly stable.
Note: Ensure the guide is fully seated in the
fossa.
6. Laser introducer
Attach a laser to the end of the curved guide handle.
Holding the guide firmly in place with the forceps,
slide the curved guide handle over the guide
assembly.
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7. Laser alignment
Attach a laser canister onto the adjustable clamp.
Lower the assembly onto the pelvic post and secure
with dial. Lower the assembly onto the pelvic screw.
Adjust the alignment of the pelvic laser to converge
with the acetabular guide laser as projected on the
ceiling or wall and secure with dial.
Note: Ensure that the pelvic laser setting is not
accidentally altered between alignment and cup
impaction.
8. Acetabular reaming
Ream the acetabulum as per the routine technique.
Note: It is recommended to remove pelvic laser
assembly from pelvic screw during reaming.
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11. Orientation confirmation
Visual confirmation of the target orientation can be
achieved by verifying that similar amounts of native
bone/osteophyte are above or below the cup rim by
referring to the reference markings on the acetabular
model.
For further visual confirmation refer to the electronic
report.
10. Cup impaction
Screw a laser canister into the magnetic impactor
adaptor and attach to the end of the cup introducer.
Place the cup in the acetabulum and adjust the
orientation until the laser converges with the pelvic
laser on the ceiling or wall. Remove the laser
adaptor from the end of the inserter and impact.
The laser adaptor can be repeatedly attached and
removed between mallet blows to control alignment
deviation during impaction.
Note: Ensure the laser adaptor and pelvic laser
assembly are always removed during impaction.
Note: It may be helpful to impact lightly to
achieve purchase in the desired orientation
before full impaction.
9. Identification of target orientation
After reaming place the pelvic laser assembly back
onto the pelvic screw. The position of the pelvic
laser on the ceiling or wall may have moved as a
consequence of the pelvis moving on the table
during reaming and retraction.
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Compatibility guide
44mm
46mm
60mm
62mm
28mm
64mm
66mm
68mm
01 05
36mm
40mm
28mm 28mm
32mm
36mm
40mm
02 03 04
Taper size
Ceramic liner
Polyethylene liner
(UHMWPE, HXLPE
and ECiMa™)
Trinity™ shell
outer diameter
Polyethylene liner
(HXLPE and ECiMa™ only)
Note: ™ compatible with BIOLOX®delta and ECiMa™ only
46mm
48mm
50mm
32mm
28mm
32mm
50mm
52mm
54mm
36mm
28mm
32mm
36mm
54mm
56mm
58mm
36mm
40mm
28mm
32mm
36mm
40mm
™™™
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Description
The Corin Optimized Positioning System™
consists of a software component and hardware
components. The software component assists
the surgeon in determining a target orientation for
the acetabular cup through a functional, dynamic
and patient specific simulation. The hardware
components consist of a patient specific guide,
bone model and reusable instrumentation to deliver
the target orientation. The system is designed to
assist the surgeon in total hip arthroplasty, and is
appropriate for all surgical approaches.
The Optimized Positioning System™ can be used
with the Trinity™ Acetabular System and the
respective compatible components.
Indications for use
The Corin Optimized Positioning System™ is
intended to be used as a patient specific surgical
instrument to assist in the orientation of the
acetabular cup intra-operatively using anatomical
landmarks of the pelvis that are clearly identifiable on
pre-operative X-rays and CT scans.
The Optimized Positioning System™ including the
Patient Specific Guides is intended for use with
the Corin Trinity™ Acetabular System for total hip
arthroplasty.
The Patient Specific Guides are intended for single
use only.
Contraindications
The Optimized Positioning System™ is
contraindicated for:
 Patients in which total hip arthroplasty is
contraindicated
 Patients with significant orthopaedic deformities,
(e.g. fused knee, hip or ankle) anatomical
disruption or distortion of the pelvis
 Patients who are unable to comply with imaging
requirements
 Patients currently receiving ionising radiation
treatment or scans for other medical conditions
 Patients with insufficient bone structure or
quality, which may not allow for rigid attachment
of instruments
 Obesity, where ability to carry out operative
technique using Optimized Positioning
System™ components is compromised
 Other disorders that affect pelvic anatomy and
bony landmark recognition
 Patients with active infection
 Any other implant system apart from the Corin
Trinity™ Acetabular System referenced above.
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The Corinium Centre
Cirencester, GL7 1YJ, UK
t: [phone]
f: [phone]
e: [email protected]
This publication is printed on stock sourced from well managed forests.
BIOLOX delta is a registered trademark of CeramTec
©2015 Corin P No I1288 Rev1 05/2015 ECR 13892
References:
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pelvic orientation measured from lateral standing and sitting radiographs.
Clin Orthop Relat Res 453:272–276
2. Echeverri S, Leyvraz P, Zambelli P, et al. Reliable acetabular cup orientation
with a new gravity-assisted guidance system. J Arthroplasty 2006;
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of recommended acetabular cup orientations for total hip arthroplasty. J.
Arthroplasty 2014
5. Yoon Y, Hodgson AJ, Tonetti J, et al. Resolving inconsistencies in defining
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93-B,4
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Surg 2007; 127:375–379