StageOne™ Select Hip Cement Spacer Molds

Surgical Technique

Description/Indications The StageOne Select Hip Cement Spacer system is a single-use silicone mold with a stainless steel reinforced stem and head intended to be filled with PALACOS® R+G Bone Cement or Refobacin® Bone Cement R*. Upon curing of the antibiotic loaded cement, the StageOne Select Hip Cement Spacer mold creates a temporary (stage one) cement spacer for patients undergoing a two-stage revision due to infection. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Note: The StageOne Select cement spacer is not intended for use for more than 180 days, at which time it must be explanted and replaced with a permanently implanted device or another appropriate treatment (e.g. resection arthroplasty, fusion, etc.)

Due to the inherent mechanical limitations of the PMMA material, the StageOne Select spacer is only indicated for patients who will consistently use traditional mobility assisted devices (e.g. crutches, walkers) throughout the implant period.

Instructions for Use After removal of the infected implants and any associated cement that is present, it is recommended to debride and copiously lavage all bone surfaces of any remaining tissue that appears infected.

Expose the acetabulum to allow for circumferential exposure. Carefully ream to debride the bone surface and assist with sizing the femoral head.

Note: In general, the femoral head size is selected so that it is 1–2 mm smaller than the last reamer utilized. An endo femoral head trial can be used to confirm sizing.

Sequentially broach the proximal femur until rotational and axial stability of the broach is achieved. The tapered reamers can be utilized to assist with debridement and bone preparation. Once stability is attained, the surgeon can then trial.

The previously selected head size is coupled to the femoral trial component using the standard neck length adaptor. The hip is then brought through range of motion to check leg length, soft tissue tension and overall stability. The neck length can be increased or decreased to optimize these parameters using the +6 mm or -6 mm neck length adaptors as judged appropriate by the surgeon.

This brochure is presented to demonstrate the surgical technique and postoperative rehab protocol of Craig Della Valle, M.D., Alexander Gordon, M.D., Gregg Klein, M.D., Harlan Levine, M.D., Edward McPherson, M.D., Kurt Merkel, M.D., and Robert Tait, M.D. Zimmer Biomet does not practice medicine. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient.

3 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Figure 1 Figure 3

Prepare cement mixture using a cartridge mixing system (Figure 1).

Snap off the mixing rod. (Figure 2).

Note: When using a compatible threaded cartridge do not attach the mixing system’s nozzle. The delivery port of the cartridge will be screwed directly to the distal mold.

Assemble the cartridge into the delivery gun (Figure 3).

Spacer Mold PreparationThe StageOne Select Hip Cement Spacer System is intended for use with PALACOS R+G Bone Cement or Refobacin Bone Cement R* and a compatible threaded cartridge mixing system.

Note: If using a cartridge with a compatible thread, firmly attach the mold directly to the cartridge. Otherwise, attach a short nozzle to the cartridge and push the end of the nozzle into the mold fill port.

To begin with spacer mold preparation, use the reference chart on page 8 as an aid to determine the estimated number of 40g batches of cement needed to fill the stem and head molds. Multiple cartridges may be needed to fill both stem and head molds at the same time.

Figure 2

4 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Filling the Stem MoldSelect appropriate stem mold size for making the hip stem cement spacer needed to fill the space vacated by the explanted prosthesis and other explanted material (Figure 4).

Note: Broaches are available for trialing before hip cement spacer stem mold is chosen.

Figure 5 Figure 6

Screw the cartridge delivery port directly to the distal threaded opening on the mold (Figure 5).

Fill the stem mold (Figure 6).

Note: Fill the mold slowly to allow the cement to flow evenly (Figure 6). Care should be taken not to overfill the mold.

Figure 4

5 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Remove the cartridge from the distal threaded port. Allow excess cement to escape out of the fill port. Screw the port plug into the distal threaded port clockwise until tight (Figure 7).

After the bone cement has cured, leave port plug in place and use a scalpel to cut open the silicone mold (Figure 8).

Note: A #12 hooked blade is recommended for facilitating in the opening of the mold.

Remove the stem spacer from the mold. Discard the mold.

Figure 8Figure 7

6 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Figure 9 Figure 11

Screw the cartridge delivery port directly to the head mold (Figure 10).

Fill the head mold (Figure 11).

Note: Fill the mold slowly to allow the cement to flow evenly. Orient mold so air vents are facing up to allow air to escape, and fully fill the mold (Figure 11). Care should be taken not to overfill the mold.

Filling the Head Mold Select appropriate head mold size for making the head cement spacer.

Note: The head spacer should be 1–2 mm smaller than the space vacated by the explanted prosthesis and other explanted material (Figure 9).

Figure 10

7 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Figure 12 Figure 13

After the bone cement has cured, leave port plug in place and use a scalpel to cut open the silicone head mold (Figure 13).

Cut 360 ˚ around the joint near the plug. Make 3 othercuts, each starting at the top of the head and coming down to the joint.

Remove the head spacer from the mold. Discard the mold.

Remove the cartridge from the distal threaded port. Allow excess cement to escape out of the fill port. Screw the port plug into the distal threaded port clockwise until tight (Figure 12).

8 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Figure 14 Figure 16Figure 15

Note: If desired, lightly coat exposed metal with piece of bone cement before implanting the hip cement spacer (Figure 16).

Instructions for Assembly and ImplantationUpon completion of creating both the stem and head spacers, choose appropriate neck length adaptor (Figure 14).

Place the neck length adaptor onto the stem’s taper followed by placing the head spacer onto the neck length adaptor. After assembled, impact the head spacer utilizing the endo head pusher (Figure 15).

9 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Figure 17

The hip cement spacer can either be press fit or cemented depending on implant stability and bone quality. If cement fixation is desired, the hip cement spacer should be fixed to bone using the identical bone cement used to form the spacer (i.e. PALACOS R+G Bone Cement or Refobacin Bone Cement R*). Apply cement to hip spacer when cement is nearing the end of the working phase.

Note: Cement should be placed proximally around the femoral stem to stabilize the hip cement spacer but deep cement penetration into bone should be avoided to facilitate the removal of the hip cement spacer before the second-stage revision (Figure 17).

Figure 18 Figure 19

Thoroughly remove all excess bone cement around the hip cement spacer (Figure 18).

Clean area again using pulse lavage, taking proper care to completely remove any loose cement particles.

Close wound.

10 | StageOne Select Hip Cement Spacer Molds Surgical Technique

StageOne Select Hip Spacer Mold Stems

Product Description Size

Estimated Number of 40g Cement Mixes Part Number

Reinforced Hip Mold StemReinforced Hip Mold StemReinforced Hip Mold StemReinforced Hip Mold StemReinforced Hip Mold StemReinforced Hip Mold StemReinforced Hip Mold StemReinforced Hip Mold StemReinforced Hip Mold StemReinforced Hip Mold Stem

9 x 125 mm11 x 135 mm13 x 145 mm15 x 155 mm17 x 165 mm9 x 200 mm11 x 200 mm13 x 200 mm15 x 200 mm17 x 200 mm

1112211222

431190431191431192431193431194431195431196431197431198431199

StageOne Select Hip Spacer Mold Heads

Product Description Size

Estimated Number of 40g Cement Mixes Part Number

Head Hip MoldHead Hip MoldHead Hip MoldHead Hip MoldHead Hip Mold

48 mm52 mm56 mm60 mm64 mm

22233

431181431182431183431184431185

StageOne Select Hip Spacer Mold Neck Length AdaptersProduct Description Size Part Number

Hip Neck Length AdapterHip Neck Length Adapter Hip Neck Length Adapter

STD+6 mm-6 mm

431186431187431188

Implants and Accessories

11 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Bone Cement and Cementing Systems

Product Description Part Number

Refobacin Bone Cement R 1x40*

Refobacin Bone Cement R 2x40*

5003940001

5003940002

PALACOS R+G with Gentamicin 40G

00111314001

Vacuum Mixing Cartridge 80g Double

414702

Cartridge Delivery Gun

414700

12 | StageOne Select Hip Cement Spacer Molds Surgical Technique

A

F

B

C D

E

Instrument Tray Detail—Tray 1

Product Description Label Size Part Number

Exact™ Stem Removal Jaw A – X31-400060

Exact EZ-Clean™ Acetabular ReamerExact EZ-Clean Acetabular ReamerExact EZ-Clean Acetabular ReamerExact EZ-Clean Acetabular ReamerExact EZ-Clean Acetabular ReamerExact EZ-Clean Acetabular ReamerExact EZ-Clean Acetabular ReamerExact EZ-Clean Acetabular ReamerExact EZ-Clean Acetabular ReamerExact EZ-Clean Acetabular Reamer

B 46 mm48 mm50 mm52 mm54 mm 56 mm58 mm60 mm62 mm64 mm

39-47614639-47614839-47615039-47615239-47615439-47615639-47615839-47616039-47616239-476164

Exact Threaded J-Hook Stem Extractor C – X31-400059

Extended Stroke Slap Hammer D – X31-400061

Exact Stem/Broach Removal Adapter E – X31-400001

Acetabular Reamer Handle F – 31-111111

13 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Instrument Tray Detail—Tray 2

A

B

C

D

Product Description Label Size Part Number

T-Handle (standard) A – 31-473620

Exact Alliance® Taper ReamerExact Alliance Taper ReamerExact Alliance Taper ReamerExact Alliance Taper ReamerExact Alliance Taper ReamerExact Alliance Taper Reamer

B 7 mm9 mm11 mm13 mm15 mm17 mm

X31-400027X31-400029X31-400031X31-400033X31-400035X31-400037

Exact Alliance Broach/ProvisionalExact Alliance Broach/ProvisionalExact Alliance Broach/ProvisionalExact Alliance Broach/ProvisionalExact Alliance Broach/ProvisionalExact Alliance Broach/Provisional

C 7 mm9 mm11 mm13 mm15 mm17 mm

X31-400007X31-400009X31-400011X31-400013X31-400015X31-400017

Exact Mallory- Head® Broach Handle D – 31-555500

14 | StageOne Select Hip Cement Spacer Molds Surgical Technique

Instrument Tray Detail—Tray 3

G

Product Description Label Size Part Number

Cinch Femoral Inserter Bullet A – 31-555613

Endo/BiPolar Trial HeadEndo/BiPolar Trial HeadEndo/BiPolar Trial HeadEndo/BiPolar Trial HeadEndo/BiPolar Trial Head

B 48 mm52 mm56 mm60 mm64 mm

31-40114831-40115231-40115631-40116031-401140

Cinch Femoral Inserter with Fork C – 31-555612

Cinch Femoral Inserter Threaded Slot D – 31-555616

Cinch Endo Head Pusher E – 31-555618

Modular Head Endo II TrialModular Head Endo II TrialModular Head Endo II Trial

F STD-6 mm+6 mm

31-40116331-40116131-401165

Echo® Trunnion Provisional 7-10, STD, RPP, NCEcho Trunnion Provisional 11-14, STD, RPP, NCEcho Trunnion Provisional 15-21, STD, RPP, NC

G –––

31-16240131-16240231-162403

Cinch Endo Trial Attachment H – 31-401169

Univeresal Thread Extractor G – 31-478350

Cinch Modular Handle H – 31-555611

A

C

D

H

B

E

F

I

J

All content herein is protected by copyright, trademarks and other intellectual property rights owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated and must not be redistributed, duplicated or disclosed without the express written consent of Zimmer Biomet. PALACOS® is a trademark of Heraeus Medical GmbH and under license from Heraeus GmbH, Germany. Refobacin® is a trademark of Merck KGaA.

This material is intended for health care professionals, Zimmer Biomet employees, and the Zimmer Biomet sales force. Distribution to any other recipient is prohibited.

For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and www.zimmerbiomet.com.

Zimmer Biomet does not practice medicine. The treating surgeon is responsible for determining the appropriate treatment, technique(s), and product(s) for each individual patient.

* Where available

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