regenerex™ ringloc®+

Transcription

regenerex™ ringloc®+
clinically proven material.
advanced porous technology.
Regenerex ringloc +
™
®
Modular Acetabular System
RingLoc +:
Next Generation
Cup Features
®
Building on the success of unparalleled RingLoc®
technology, the new RingLoc®+ shell design offers
next generation cup features paired with advanced
Regenerex™ porous titanium construct.
Extended rim
Designed to prevent soft
tissue entrapment between
shell and liner
Regenerex™ Porous Titanium
Construct
Unites clinical history of titanium with
an enhanced interconnecting pore
structure for rapid bone ingrowth.
Un-lock/re-lock mechanism
Allows for easy disassembly
without damaging the liner**
Solid
Limited hole
Large dome hole
Designed for ease of insertion
Multi-hole
**Any time the liner is removed, it is recommended that the locking ring be removed and replaced with a new one. If the liner is damaged in any way, a new liner should be utilized.
1
RingLoc : Unparalleled
locking technology
®
Biomet’s RingLoc® acetabular components have
redefined the standard of acetabular technology.
Testing by independent laboratories has rated
RingLoc® technology among the highest in terms of
push-out, lever-out and congruity of the implant as well
as the lowest in micromotion.2–5
Unparalleled RingLoc® locking technology
Achieves maximum push-out and lever-out
strength with lowest micromotion of
independently tested competitive systems2–5
Fully congruent design
Maximizes congruency at the
liner-to-shell interface to help
minimize micromotion
2
Volumetric Wear1
5 million cycles on a hip simulator
28mm head size
60
53.3
50
Six or eight tabs create an
interference fit with the notches on
the liner to provide for maximum
rotational stability and minimum
micromotion
Volumetric Wear Rate
mm3/106 Cycles
Anti-rotational tabs
40
29.4
30
20
10
0
0.24
Non-HXLPE
ArComXL®
HXLPE
E-Poly™
HXLPE
Ultra-low wear with large heads
Combine with E-Poly™ HXLPE for the
optimal combination of fixation and
low wear. 40mm E-Poly™ liners
demonstrated 95% lower wear than
36mm clinically proven ArCom® liners6
3
versatile modular design featuring
Regenerex porous titanium construct
™
Regenerex™ Porous Titanium Construct is a revolutionary technology engineered for rapid bone ingrowth by
uniting the proven clinical history of titanium with an enhanced interconnecting pore structure.
Integrated with Biomet’s unparalleled RingLoc® technology, only the Regenerex™ RingLoc®+ Modular Shell
offers new next generation RingLoc®+ cup features, which have been engineered to meet the needs of the
orthopedic community.
Rapid bone integration
Initial stability
• Two weeks after insertion, Regenerex™ implants
• 16% rougher than Trabecular Metal,™ 6 the initial
displayed bony integration and vascularization.
• In similar canine studies, Regenerex material
™
scratch-fit, stability and fixation of Regenerex™ implants
is well-suited for acetabular reconstruction.
demonstrated more rapid ingrowth than Zimmer’s
Trabecular Metal.™6
BONE INGROWTH1,6
Average Roughness (Ra)
2500
100
100
2079.2
80
2000
40
60
40
Regenerex™ material6,7
Trabecular Metal ™5
20
0
20
Microinch
% Bone in Void Area
% Bone in Void Area
80
60
2485.6
1500
1000
No testing data available
2 Weeks
4 Weeks
16 Weeks 26 Weeks 52 Weeks
500
0
2 Weeks
4 Weeks 16 Weeks 26 Weeks 52 Weeks
0
4
Regenerex
™
6
Trabecular Metal
™
6
Strong, yet flexible
• 300% stronger than Trabecular Metal™ under
compressive loads1, which reduces the risk of
material failure.
• Maintains a compressive modulus similar to
cancellous bone.
Peak compressive stress
300
compressive modulus
20
270
18
250
15
157
GPa
MPa
200
150
10
100
50
50
5
2
21
0
Cortical
Bone8,9
Cancellous Regenerex™ 6 Trabecular
Bone8,9
Metal™10
0
Cortical
Bone8,9
1.9
Cancellous Regenerex™ 6
Bone8,9
1.5
Trabecular
Metal™10
5
RingLoc technology:
Proven after 15 years
of clinical use
®
Maximum Motion
Any Sensor, Any Condition
200
Various forces including toggling, levering and rotation are present
150
component life and help reduce potential debris generation, the
shell-to-liner locking mechanism must be sound. Independent labs
have consistently rated Biomet’s RingLoc® cups among the best.
• Proven to be a superior locking mechanism for polyethylene
Micrometers
during normal acetabular kinematics. To extend acetabular
100
50
liners2–5
• High strength of the locking mechanism helps prevent liner
disassociation from the shell
• Fully supported liner for even stress distribution
• Lowest micromotion of all tested systems to help eliminate
debris generation
6
0
Biomet
Ringloc®
Smith &
Nephew
Reflection®
Zimmer
Trilogy®
Data derived from Fehring TK, Smith SE, Braun ER, Mobley CE, Wang PL, Griffin WL:
Motion at the Modular Acetabular Interface: A Competitive Study. Scientific Exhibit
presented at the American Academy of Orthopaedic Surgeons. 62nd
Annual Meeting. Atlanta, GA. 1996.
Strength of the locking mechanism to help prevent liner
disassociation from the shell
System
Name
Initial Push-Out
Initial Lever-Out
Zimmer
Trilogy®
722+
408+
Biomet
Ringloc®
660+
660+
DePuy
Duraloc®
663
647
Smith &
Nephew
Reflection®
65
92
0
100
200
300
400
500
600
700
800
0
100
200
300
400
500
600
700
800
Torque [in-lbf]
Force [lbf]
Trodonsky, S. et al.: Performance Characteristics of Two-Piece Acetabular Cups. Scientific Exhibit presented at the American
Academy of Orthopaedic Surgeons. 59th Annual Meeting. San Francisco, CA. 1992.
Trodonsky, S. et al.: Performance Characteristics of Two-Piece Acetabular Cups Series II. Scientific Exhibit
presented at the American Academy of Orthopaedic Surgeons. 62nd Annual Meeting. Atlanta, GA. 1996.
This data is the property of the Orthopaedic Research Laboratories of the Mt. Sinai Medical Center, Cleveland Ohio. The
reproduction and distribution of this data are restricted.
Support of the liner leading to even stress distribution
to help improve liner life
System
Name
Percent (%) of Unsupported Polyethylene
Contact Area of Supported Polyethylene (sq. cm)
Smith &
Nephew
Reflection®
13.5
24.1
Biomet
Ringloc®
15.4
21.1
Zimmer
Trilogy®
27.6
20.8
DePuy
Duraloc®
34.1
16.7
0
5
10
15
20
25
30
35
0
5
10
15
20
25
Data derived from Rosner BI, Postak PD, Greenwald AS: Cup Liner Conformity of Modular Acetabular Designs. Scientific
Exhibit presented at the American Academy of Orthopaedic Surgeons. 61st Annual Meeting. Orlando, FL. 1995.
Data derived from Rosner BI, Postak PD, Greenwald AS: Cup/Liner Incongruity of Two Piece Acetabular Designs: Implications
in the Generation Polyethylene Debris. Scientific Exhibit presented at the American Academy of
Orthopaedic Surgeons. 60th Annual Meeting. New Orleans, LA. 1994.
This data is the property of the Orthopaedic Research Laboratories of the Mt. Sinai Medical Center, Cleveland Ohio. The
reproduction and distribution of this data are restricted.
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versatility when you need it most…
Multiple augment options
• Designed to help maximize acetabular stability
• Available in 12 sizes with multiple screw holes
• Augments can be stacked for complex reconstruction
• Ideal option for complicated revision surgery
Multiple liner configurations
• Available in…
8
Max-Rom™ Liner
10-Degree Liner
Hi-Wall Liner
+5mm Hi-Wall Liner
Ultra-low wear with large heads
• Combine with E-Poly™ HXLPE for the optimum
combination of fixation and low wear
• 40mm E-Poly™ liners demonstrated 95% lower wear
than 36mm ArCom® liners6
Maximum resistance to dislocation
• Combine with Biomet’s Freedom® Constrained Liner
for patients at high dislocation risk
• Allows for 110 degrees range of motion
• Multiple liner options
References
1. Data on file at Biomet. Bench test results not necessarily indicative of clinical performance.
2. Fehring, T.K. et al. Motion at the Modular Acetabular Interface: A Competitive Study.
Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 62nd
Annual Meeting. Atlanta, GA. 1996.
3. Rosner, B.I. et al. Cup Liner Conformity of Modular Acetabular Designs. Scientific Exhibit
presented at the American Academy of Orthopaedic Surgeons. 61st Annual Meeting.
Orlando, FL. 1995.
4. Rosner, B.I. et al. Cup/Liner Incongruity of Two Piece Acetabular Designs: Implications in the
Generation of Polyethylene Debris. Scientific Exhibit presented at the American Academy of
Orthopaedic Surgeons. 60th Annual Meeting. New Orleans, LA. 1994.
5. Trodonsky, S. et al. Performance Characteristics of Two-piece Acetabular Cups. Scientific
Exhibit presented at the American Academy of Orthopaedic Surgeons. 59th Annual
Meeting. San Francisco, CA. 1992.
6. Data on file at Biomet. Testing done on animal models.
7. Bobyn, J.D. et al. Characteristics of Bone Ingrowth and Interface Mechanics of a New
Porous Tantalum Biomaterial. Journal of Bone and Joint Surgery (British). 81-B(5): 907, 1999.
8. Keaveny, T.M. and Hayes, M.C. Bone, Volume 7: Bone Growth – B. B. Hall BL (Ed). CRC
Press. Boca Raton, FL. 285–344, 1992.
9. Wirtz, D.C. et al. Critical Evaluation of Known Bone Material Properties to Realize Anisotropic
FE-simulation of the Proximal Femur. Journal of Biomechanics. 33(10): 1325–30, 2000.
10. Zardiackas, L.D. et al. Structure, Metallurgy and Mechanical Properties of a Porous Tantalum
Foam. University of Mississippi Medical Center. 2000.
All trademarks belong to Biomet Manufacturing Corp. unless otherwise noted.
Trabecular Metal™ and Trilogy® are trademarks of Zimmer, Inc.
Duraloc® is a registered trademark of DePuy.
Reflection® is a registered trademark of Richards Smith & Nephew, Inc.
For product information, including indications, contraindications, warnings, precautions and potential adverse
effects, see the package insert and Biomet’s website.
This material is intended for the sole use and benefit of the Biomet sales force and physicians. It is not to be
redistributed, duplicated or disclosed without the express written consent of Biomet.
P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501
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