COPAL® exchange G - Preformed Spacers for Supporting PJI Treatment

COPAL exchange G Hip and Knee Spacers in different dimensions
COPAL exchange G Hip Spacer
COPAL exchange G Knee Spacer
COPAL exchange G Hip and Knee Spacer

Meet Your Element of Success in Infection Management

In addition to being a clinically devastating complication, periprosthetic joint infections (PJI) in the U.S. number over 30,000 annually, with a yearly cost exceeding $1.62 billion.1 Which is why it is more important than ever to have an effective, efficient, go-to solution within reach.

For two-stage revision procedures, COPAL® exchange G integrates minimized wear2 and outstanding stability into an easy-to-use preformed design. All to help orthopedic surgeons increase efficiency, efficacy, and reduce OR time. Our easy-to-distinguish trial accessory devices also allow for precise determination of the correct spacer sizing during surgery.

COPAL® exchange G: Advantages at a Glance

With experience and expertise earned from over 34 million procedures and more than 60 years of manufacturing, PALACOS® cements - optimized for efficacy in COPAL® exchange G spacers - are extensively proven,3 highly dependable, and widely respected.

Available for hip and knee, our preformed spacers offer numerous advantages over the time-intensive, inconsistent process of manual admixing and spacer formation:

  • Improve Patient Comfort with implant-styled, reinforced metal hip inlays and 63.7% less pro-inflammatory particle wear.2**
  • Increase Patient Mobility with highly congruent articulation for increased flexion and reduced friction, and 11 size variants for optimal patient fit.
  • Reduce Reinfection Risk by reducing O.R. times by up to 15 minutes,5 and extending antibiotic efficacy over 42 days.10*

* As tested in vitro for Staph. aureus and E. coli bacteria.

** Versus Exactech Interspace knee spacers.

PJI is Devastating, Make Recovery Less So with COPAL® exchange G:

Preformed for Optimized Performance

The COPAL® exchange G portfolio features a range of sizes to accommodate patient needs. For the hip, choose between a variety of stem lengths, head sizes, and medial widths to fit patients with varying degrees of bone loss, as well as variances in patient natural bone size.

For knees, our spacers provide a range of motion over 90 degrees for increased flexion. The single radius design of the femur and highly congruent articulation of the femoral and tibial components are designed to improve stability and lower the risk of dislocation.

For a full list of dimensions, please reach out to us  here .

COPAL® exchange G Hip Offerings

Product Description Dimension REF
S short Preformed Hip Spacer with Gentamicin - Small Head, Short Stem 46 mm Head x 135 mm Stem 5034793
M short Preformed Hip Spacer with Gentamicin - Medium Head, Short Stem 54 mm Head x 135 mm Stem 5034791
L short Preformed Hip Spacer with Gentamicin - Large Head, Short Stem 60 mm Head x 135 mm Stem 5034788
S medium Preformed Hip Spacer with Gentamicin - Small Head, Medium Stem 46 mm Head x 184 mm Stem 5147215
M Medium Preformed Hip Spacer with Gentamicin - Medium Head, Medium Stem 54 mm Head x 184 mm Stem 5147216
S long Preformed Hip Spacer with Gentamicin - Small Head, Long Stem 46 mm Head x 251 mm Stem 5034792
M long Preformed Hip Spacer with Gentamicin - Medium Head, Long Stem 54 mm Head x 251 mm Stem 5034790
L long Preformed Hip Spacer with Gentamicin - Large Head, Long Stem 60 mm Head x 251mm Stem 5034785

COPAL® exchange G Hip Trial Offerings

Product Description Dimensions REF
S Trial Set Hip Trial Set containing Small Heads, with Short, Medium and Long Stem Lengts 46 mm Head Trial Set 5092608
M Trial Set Hip Trial Set containing Medium Heads, with Short, Medium and Long Stem Lengts 54 mm Head Trial Set 5092613
L Trial Set Hip Trial Set containing Large Heads, with Short and Long Stem Lengts 60 mm Head Trial Set 5092614

COPAL®exchange G Knee Offerings

Product Description Dimensions REF
Small Knee Set Preformed Knee Spacer with Gentamicin 54 mm femur x 54 mm tibia 5092608
Medium Knee Set Preformed Knee Spacer with Gentamicin 64 mm femur x 64 mm tibia 5092613
Large Knee Set Preformed Knee Spacer with Gentamicin 74 mm femur x 74 mm tibia 5092614
Knee Trial Set Trial Set containing Small, Medium and Large Knee sizes All Knee sizes included 5092607

PALACOS® perfected cement formula for COPAL® exchange G Spacer use.

The most studied bone cement ever,3 PALACOS® bone cements have been used in over 34 million joint replacement cases worldwide, and have been optimized for efficacy and reduced friction4,11 in COPAL® exchange G spacers.

Created using a state-of-the art, proprietary one-piece molding process for a remarkably smooth surface, COPAL® exchange G spacers are both the only green preformed spacer on the market and the only currently available preformed spacer formulated with the radiopacifier calcium carbonate (CaCO3) instead of the traditional barium sulfate.2 As calcium carbonate is water soluble, this radiopacifier choice lessens the potential of hazardous wear particles in the body, while also increasing the antibiotic efficacy of the spacer.4

  • COPAL® exchange G’s smooth surface quality is perceived to result in lower friction during articulation****
  • Fewer abrasive and pro-inflammatory wear-particles due to unique cement formula.4
  • PALACOS®-green color provides bright contrast against patient bone bed.7
  • Hydrophilic cement matrix provides extended antibiotic efficacy.6,8

****Gathered from US surgeon opinion, 2022

Increase Your Antibiotic Efficacy Against PJI

PJI is notoriously difficult to treat due to it’s broad spectrum of infection-causing bacteria and the prevalence of prosthesis-bound biofilms. Since the first spacer introduction in the 1980s,9 the field has been constantly evolving to provide surgeons and patients more effective and efficient treatment methods. COPAL® exchange G preformed spacers are proud to continue the path of PJI innovation.

Developed with the same base structure and strong antibiotic profile as PALACOS® cements with gentamicin, COPAL® exchange G preformed spacers take increased elution kinetics to the next level - extending their antibiotic efficacy over 42 days (see graph below).6

Intended to further optimize their elution profile, the cement used in the creation of COPAL® exchange G spacers is created with calcium carbonate (CaCO3) instead of traditional barium sulfate, which allows for an increase in antibiotic release.4

COPAL exchange G Antibiotic inhibition

Limit Spacer Friction in Knees…and Hips.

Generally, articulating spacers are preferred over static spacers if the patient’s health allows.9,10 However, the resulting articulation during joint movement results in increased friction and particle wear over the life of the spacer. The presence of these wear particles in the body have been associated in proinflammatory reactions, osteolysis, and potentially decreased performance of the final prosthesis.4,11,16-17

In comparative testing, COPAL® exchange G knee spacers were found to minimize this pro-inflammatory and osteolysis-inducing wear by up to 63.7% vs competitor spacers. The released wear particulates were also found to be 1/3 smaller with COPAL® exchange G than with competitor spacers.4

COPAL® exchange G hip spacers were found to provide increased resistance to in-vitro wear cycles and visually, fewer wear particles and a smoother surface were noted both before and after running testing.14-15

PJI is a devastating complication with serious complications for patient quality of life. With the help of articulating spacers, patients may be able to continue with activities of daily living throughout revision interims.10 As traditional spacers are associated with various complications,19 it is Heraeus Medical’s goal to provide a more robust and mechanically stronger solution.

COPAL® exchange G spacers are that solution.

To ensure this, all COPAL® exchange G products have undergone rigorous in-vitro compression and fatigue testing. Additionally, all COPAL® exchange G hip spacers are embedded with an implant-styled reinforced metal inlay which runs from the top of the spacer head to the distal stem and is strengthened at the neck of the spacer for additional durability when compared to handmade spacers without metal inlays.

For Hip Spacers:

After 6-months of cyclical fatigue stress (500,000 steps at 1,200 lbs), COPAL® exchange G hip spacers showed no visible damage (see graph below). At that same stress level, competitor hip spacers presented multiple fractures.

For Knee Spacers:

After 6-months of cyclical fatigue stress (500,000 steps at 200 lbs), COPAL® exchange G knees showed no breakage (see graph below). During testing, competitor spacers were unable to withstand the same amount of stress.6

Comperative fatigue strength results of COPAL exchange G with Competitors

Preformed Spacers: Your Immediate Infection Management Solution

Preformed spacers provide a variety of benefits unmatched by traditional handmade and molded bone cement spacers.18,20

The most considerable benefit to preformed spacers can be clearly seen in the consistent sizing, quality, and reliable elution rates from case to case. Preformed spacers also allow for increased mechanical strength. An excellent example of this, COPAL® exchange G hip spacers are formed around a reinforced metal inlay to strengthen implant durability6 and facilitate patient mobility during the interim phase of a 2-stage exchange surgery.18

Overall, preformed spacers are a cost-effective4,13 and safe solution for infection management in total joint revisions.

  • FAST: Reduced OR time by up to 15 minutes*** minimizes further infection risk5 and lessens the economic impact on facilities by up to $735.4,13
  • CONSISTENT: Engineered for consistent, reproducible sizing, elution rates, and mechanical stability from batch-to-batch.
  • MOBILE: Proven to facilitate patient mobility during 2-stage revision interims7,18
  • STABLE: Proven to result in significantly fewer structural complications; including fracture, instability, and subluxation.
  • SECURE: Receive peace of mind with limited surgeon product liability.(when used according to manufacturer IFUs)
  • SIMPLE: Ready to use for immediate implantation.

***Compared to complete polymerization cycle for a handmade or moulded spacer. Time saved will vary based on environmental factors and cement type.

1 Kurtz et al. (2012), Economic Burden of PJI in the US. The Journal of Arthroplasty 2012, Vol. 27 No. 8 Suppl.

2 COPAL® exchange G IFU, Heraeus Medical.

3 Pilz V, Hanstein T., A Literature Review of the Clinical Evidence Situation of Bone Cements. Journal of Medical and Health Sciences. 2018;1:31-6.

4 Mueller U, et al (2017), Wear performance of calcium carbonate-containing knee spacers. Materials 2017, 10 (7), 805

5 Dalstrom DJ, et al. Time-Dependent Contamination of Opened Sterile Operating Room Trays. J Bone Joint Surg Am 2008; 90(5): 1022-5.

6 Data on File. Heraeus Medical. (2020)

7 Kuehn KD.: PMMA Cements - Are we aware of what we’re using?. Springer Verlag, 2014, p.81-2.

8 Heraeus Medical PMMA formula.

9 Borden LS, Gearen PF. Infected Total Knee Arthroplasty: a Protocol for Management. J Arthroplasty.

10 Romano, C. L., et al. (2012). Two-stage revision of septic knee prosthesis with articulating knee spacers yields better infection eradication rate than one-stage or two-stage revision with static spacers. Knee Surg. Sports Traumatol. Arthrosc. 20(12), 2445-53

11 Fink, B., et al. Articulating spacers used in two-stage revision of infected hip and knee prostheses abrade with time. Clin. Orthop. Relat. Res. 2011, 469, 1095–102.

12 Peterson J, et al. A Comparison of Relative Value Units in Primary Versus Revision Total Knee Arthroplasty. J Arthroplasty 2018; 33(7S): S39-42.

13 Childers CP, Maggard-Gibbons M. Understanding Costs of Care in the Operating Room. JAMA Surg 2018; 153(4): e176233.

14 Vogt S., Paul, R. (2014). Test Report No. 508.131112.10.2022. EndoLab.

15 Vogt S., Paul, R. (2013). Test Report No. 508.130416.10.1908. EndoLab.

16 Wimhurst, J.A.; Brooks, R.A.; Rushton, N. The effects of particulate bone cements at the bone-implant interface. J. Bone Jt. Surg. Br. Vol. 2001, 83, 588–92.

17 Sun, S.G., et al. Effects of bone cement particles on the function of pseudocapsule-derived fibroblasts. Acta Orthop. 2006, 77, 320-8.

18 Rava, A., et al. (2019). Hip Spacers in Two-Stage Revision for PJI: A Review of Literature. Joints, 7(2), 56-63.

19 MAUDE database, FDA, retrieved

20 Citak M, et al. Are Preformed Articulating Spacers Superior to Surgeon-Made Articulating Spacers in the Treatment of PJI in THA? A Literature Review. Open Orthop J 2015; 9: 255-261.