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

Preformed Spacers and Trials, for Ready-Made Efficiency

For two-stage revision procedures, COPAL® exchange G preformed spacers integrate minimized wear and outstanding stability into an easy-to-use preformed design - all to help orthopedic surgeons maximize efficiency, increase 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 Preformed Spacers

With experience and expertise earned from over 30 million procedures and more than 60 years of manufacturing, PALACOS® cements - optimized for efficacy in COPAL® exchange G spacers - are extensively proven, 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:

  • Reduced OR time vs. handmade and molded spacers
  • Sized for optimal patient fit with 11 size variants
  • Fracture-resistant reinforced metal inlays provide stability and safety (hip only)
  • Consistent, reproduceable antibiotic efficacy extends over 42 days*
  • Created with an innovated molding process and unique composition to minimize pro-inflammatory and osteolysis-inducing wear by up to 63.7%1**

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

** Versus Exactech Interspace knee spacers.

PALACOS® cements containing Gentamicin are known for eluting a higher proportion of antibiotic to surrounding tissue2 and the initial high dose released through antibiotic-loaded PALACOS® cements matches the period when the risk of infection is the highest - enabling the effective elimination of bacterial pathogens3-7.

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.** Chosen for its' increased elution rates, small molecule size, and broad range of antibiotic efficacy, gentamicin – the antibiotic of choice for all PALACOS® and COPAL® exchange G products – is effective against 70% of PJI-causing bacteria8

To further optimize the elution characteristics of our COPAL® exchange G spacer products, the cement used in the creation of COPAL® exchange G spacers are created with Calcium Carbonate (CaCO3) in place of the traditional x-ray contrast medium of Zirconium Dioxide (ZrO4). This exchange allows for an increase in antibiotic release, and results in less abrasion and wear-particles over the life of the spacer.1

* In the United States, PALACOS® R+G, PALACOS® MV+G, PALACOS® LV+G and PALACOS® fast R+G are indicated for use in the second stage of a two stage revision for the total joint arthroplasty after the initial infection has been cleared.

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

Preformed spacers provide a variety of benefits unmatched by traditional handmade and molded bone cement spacers.9-10

The most considerable benefit to preformed spacers can be clearly seen in the consistent sizing, quality, and reliable elution rates from case to case. For example, COPAL® exchange G preformed spacers are developed using a proprietary one-piece molding process that allows for consistent sizing and minimal particle wear batch-to-batch. 

Preformed spacers also allow for increased mechanical strength through added components in the manufacturing process. COPAL® exchange G hip spacers are formed around a reinforced metal inlay to strengthen implant durability11 and facilitate patient mobility during the interim phase of a 2-stage exchange surgery.10

COPAL exchange G Knee Spacer Trial Bundle

Developed to take the guess work out of spacer sizing, COPAL exchange G Knee Spacer Trials are available in a single bundle. (Including S,M, & L form sizes.)

Knee Spacer Trial Dimensions:
S: 54mm femur & 53mm tibia
M: 64mm femur & 64mm tibia
L: 74mm femur & 74mm tibia

COPAL exchange G Hip Spacer Trial Bundles

Developed to take the guess work out of spacer sizing, COPAL exchange G Hip Spacer Trials are available in four bundles based on head size (S,M,L,XL), that include both short and long stem lengths.

Hip Spacer Trial Bundle Dimensions:
S: 46mm head w/ 135mm & 251mm stems
M: 54mm head w/ 135mm & 251mm stems
L: 60mm head w/ 135mm & 251mm stems
XL: 65mm head w/ 135mm & 251mm stems

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

2 Modified from Furnes et al.: Properties of bone cement: Which bone cement should we choose for primary THA, in:Breusch S.J., Malchau H.; The well-cemented total hip arthroplasty. Springer 2005; 104

3 Kuehn K.D: PMMA Cements. Springer 2014; 147.

4 Webb, J.CJ., Spencer, R.F The role of polymethacrylate bone cement in modern orthopaedic surgery. JBJS, 2007, 89B-7:855.

5 Gristina A. et al. Infections from biomaterials and implants: a race for the surface. Medical progress through technology 1988; 14:204-5:218.

6 Meyer J, Piller G, Spiegel CA, Hetzel S, Squire M. Vacuum-mixing significantly changes antibiotic elution characteristics of commercially available antibiotic-impregnated bone cements. J Bone Joint Surg Am. 2011 Nov 16;93(22):2049-56. doi: 10.2106/JBJS.J.01777.

7 Wahlig H, Dingeldein E. Antibiotics and bone cements. Experimental and clinical long-term observations. Acta Orthop Scand. 1980 Feb;51(1):49-56. doi: 10.3109/17453678008990768.

8 Zimmerli W. Bone and Joint Infections. 2015; 132. 

9 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.

10 Rava, A., et al. (2019). Hip Spacers in Two-Stage Revision for Periprosthetic Joint Infection: A Review of Literature. Joints, 7(2), 56–63. https://doi.org/10.1055/s-0039-1697608

11 Data on File. Heraeus Medical.