References - Künstliche Gelenke | Gelenkersatz | … literature...StageOne Select Hip Cement Spacer Molds Interchangeable Sizing for a Structured Fit The StageOne Select Hip Spacer

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References1. Cui Q, Mihalko WM, Shields JS, Ries M and KJ Saleh. Antibiotic-

Impregnated Cement Spacers for the Treatment of Infection Associated with Total Hip or Knee Arthroplasty. The Journal of Bone & Joint Surgery. 89:871–882. 2007.

2. DataonfileatBiomet.Benchtestresultsnotnecessarilyindica-tive of clinical performance.

3. Report from SP Technical Research Institute of Sweden (2007 08 13). Airborne methyl methacrylate monomer during the use of differ-ent bone cement mixing systems.

4. Schlegel UJ, Sturm M, Eysel P, Breusch SJ. Pre-Packed Vacuum Bone Cement Mixing Systems. A Further Step in Reducing Methlymethacrylate Exposure in Surgery. Ann. Occup. Hyg. 2010 June 30, pp. 1-7.

5. Wang J-S, Franzén H, Jonsson E, Lidgren L. Porosity of bone cement reduced by mixing and collecting under vacuum. Acta Orthop Scand 1993, 64 (2): 143-146.

6. Wang J-S, Kjellson F. Bone Cement Porosity in Vacuum Mixing Systems, Bone Cements and Cementing Technique 2001, Walenkamp, Murray (Eds). Springer Verlag.

7. Malchau H, Herberts P, Garellick G, Söderman P, Eisler T. Prognosis of Total Hip Replacement. Scientific Exhibition pre-sented at the 69 the Annual meeting of the American Academy of Orthopaedic Surgeons. February 13-17, 2002, Dallas.

8. Dunne N-J, Orr J.F. Influence of themixing techniques on thephysical properties of acrylic bone cement. Biomaterials 2001; 22: 1819-1826.

9. Wilkinson J.M., Stockely I, et al. Effect of mixing techniques on the Properties of Acrylic Bone-Cement, The Journal of Arthroplasty, 2000; 15:663-667.

10. Bassam A. Masri, Clive P. Duncan, Christopher P. Beauchamp, Nancy J. Paris, Jennifer Arntorp. Effect of Varying Surface Patterns on Antibiotic Elution from Antibiotic-loaded Bone Cement.The Journal of Arthroplasty Vol. 10, No. 4, 1995, 453-459.

11. Meding, J.B., et al.: “Minimum Ten-Year Follow-Up of a Straight-Stemmed, Plasma-Sprayed, Titanium-Alloy, Uncemented Femoral Component.” Presented at AAOS, San Francisco, CA, February 28 – March 4, 2001.

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StageOne Select Hip Cement Spacer Molds

Over 1 million times per year, Biomet helps one surgeon

provide personalized care to one patient.

The science and art of medical care are to provide the right

solution for each individual patient. This requires clinical

mastery, a human connection between the surgeon and the

patient, and the right tools for each situation.

At Biomet, we strive to view our work through the eyes of

one surgeon and one patient. We treat every solution we

provide as if it’s meant for a family member.

Our approach to innovation creates real solutions that assist

each surgeon in the delivery of durable personalized care

to each patient, whether that solution requires a minimally

invasive surgical technique, advanced biomaterials or a

patient-matched implant.

When one surgeon connects with one patient to provide

personalized care, the promise of medicine is fulfilled.

One Surgeon. One Patient.


More options while increasing mobility for the patient

Biomet offers high-quality, customizable

StageOne Select hip cement spacer

molds that optimize patient fit, and

provide the surgeon with more options

while increasing mobility for the patient.

The antibiotic-impregnated PMMA bone cement

spacer is intended for use in patients undergoing

a two-stage revision procedure due to a septic

process. Studies have shown that the use of

articulating spacers in the first stage maintains

better soft tissue tension, allows for a greater

degree of joint motion, facilitates second-stage

reimplantation and results in a better outcome

when compared to the use of static spacers.1

1


Interchangeable Sizing for a Structured Fit

The StageOne Select Hip Spacer System consists

of independent femoral and acetabular molds

with interchangeable sizing options to create an

articulating hip spacer accommodating various

patient anatomies. Featuring a reinforced stem

for increased spacer strength and modular neck

length options to adjust leg length and retain soft

tissue tension, the StageOne Select Hip Spacer

is an innovative way to care for patients.

Modular Neck Length Adaptor Options

• Designed to adjust leg length, retain soft tissue tension, and provide structural stability

Stem Design

• Based on Echo Bi-Metric broach

• Ensures spacer has maximum possible bone-to-cement interface

Independent Femoral and Acetabular Articulating Spacers

• Permits a greater degree of joint motion and improved function prior to the second-stage reimplantation when compared to non-articulating spacers1

Textured Surface

• Increases surface area to promote higher antibiotic elution2

2


5 Interchangeable Head Options

• Available in 48 mm, 52 mm, 56 mm, 60 mm and 64 mm sizes

• Complement the most commonly encountered acetabular sizes

3 Modular Neck Length Adaptor Options

• Available in -6 mm, STD and +6 mm

• Stainless steel construct

10 Interchangeable Options

• Standard (125 mm – 165 mm) and revision length spacers (200 mm)

• Revision length stems are tapered proximally and are cylindrical distally to better match patient anatomy

• Available in 9 mm, 11 mm, 13 mm, 15 mm and 17 mm sizes

Modular Neck Length Adaptor Options

• Designed to adjust leg length, retain soft tissue tension, and provide structural stability R

evis

ion S

tand

ard

Head Design

• Based on Endo Bi-Polar primary head

3


Mold Filling Options

Optivac

• Proven system and on the market since 1993 5,6,7,8,9

• Easy and convenient mixing• Flexible system, many sizes

For the filling of the StageOne Select hip spacer

molds Biomet recommend the use of the bone

cement mixing and delivery system e.g. the proven

and well documented Optivac that can be filled with

antibiotic loaded bone cement.

4


Threaded Port

Creates a seamless delivery of cement from the Optivac to the mold.

5


Textured Surface

• Increases the surface area on the temporary hemi-hip prosthesis

• Provides a greater antibiotic elution than that of a matte or shiny surface*,2,10.


• Fully customizable to patient needs

• 150 interchangeable sizing options to match patient anatomy and bone defects – bone sparing, allows for a greater degree of joint motion, facilitates second-stage reimplantation and results in a better patient outcome when compared to the use of static spacers1

• Neck length adaptor options maintain soft tissue tension

• Stainless steel reinforcement provides increased strength

• Design based on the Echo Bi-Metric system which has a long clinical history

Hip Cement Spacer Mold Range

Biomet offers three options for surgeons when

treating an infected primary prosthesis. The

StageOne Select Hip Cement Spacer System

provides 150 interchangeable sizing options

for creating a temporary, articulating hip spacer

accommodating various patient anatomies.

StageOne Reinforced Hip Cement Spacer Molds

create 4 different sizes of stainless-steel reinforced,

temporary hip spacers for treating an infected

total joint. StageOne Hip Cement Spacer Molds

also come in 4 sizes. These three options allow

surgeons to choose the optimal solution for each

unique patient situation.

6


StageOne Reinforced Hip Cement Spacer Molds

• Spacer design based on clinically proven Biomet hip geometry11 • Spacer helps retain the patient’s natural range of motion

• Designed to mold a temporary hip spacer for patients undergoing a two-stage revision due to an infected total joint

• Spacer preserves the soft tissue envelope for second stage re-implantation

• 4 Sizes; 9x125x43 mm, 9x125x51 mm, 13x145x57 mm and 17x165x64 mm

StageOne Hip Cement Spacer Molds

• StageOne hip cement spacer molds possess the same features as the StageOne reinforced hip cement spacer molds without the reinforced core

• 4 Sizes; 9x125x43 mm, 9x125x51 mm, 13x145x57 mm and 17x165x64 mm

*Bench top testing suggests the Day 1 gentamicin elution of a dimpled surface disc sample is more than twice that of a shiny surface and 20% higher than a matte surface. By Day 5 the gentamicin elution for a dimpled surface is 52% higher than a shiny surface and 23% higher than a matte surface 2,10.

7


Implants

StageOne Select Hip Spacer Mold Stems

ProductPart

NumberDescription Size

Estimated Number of Bone Cement Mixes

(40g)

431190

431191

431192

431193

431194

431195

431196

431197

431198

431199

Reinforced Hip Mold Stem










9 x 125 mm

11 x 135 mm

13 x 145 mm

15 x 155 mm

17 x 165 mm

9 x 200 mm

11 x 200 mm

13 x 200 mm

15 x 200 mm

17 x 200 mm

1

1

1

2

2

1

1

2

2

2

StageOne Select Hip Spacer Mold Heads

ProductPart


Estimated Number of Bone Cement Mixes

(40g)

431181

431182

431183

431184

431185

Head Hip Mold

Head Hip Mold

Head Hip Mold

Head Hip Mold

Head Hip Mold

48 mm

52 mm

56 mm

60 mm

64 mm

2

2

2

3

3

StageOne Select Hip Spacer Mold Neck Length Adaptors

ProductPart


431186

431187

431188

Hip Neck Length Adaptor



STD

+6 mm

STD -6 mm

8


Product Range

Cementing Systems

Product Part Number Description

4161Optivac S

For a single mix of 20 gram to 40 gram cement

4160Optivac M

For a double mix of 60 gram to 80 gram cement

4152 Optivac L

For a triple mix of 100 gram to 120 gram cement

4150Optivac Hip Set

For two cement mixings, e.g. 40 gram and 80 gram

4195 Optigun Ratchet

9

Documents

References - Künstliche Gelenke | Gelenkersatz | … literature...StageOne Select Hip Cement Spacer Molds Interchangeable Sizing for a Structured Fit The StageOne Select Hip Spacer