Orthopedic surgery bone cement COPAL® G+C

Overview
COPAL® G+C is an antibiotic-loaded, high-viscosity polymethylmethacrylate (PMMA) bone cement combining gentamicin and clindamycin for local infection prophylaxis and management in arthroplasty. The formulation provides an initial high local antibiotic release and broad coverage against pathogens commonly implicated in prosthetic joint infection (PJI).

Key features

• High-viscosity PMMA bone cement with dual antibiotics
• Contains 1 g gentamicin and 1 g clindamycin per unit
• Radiopaque formulation
• Coloured green (colorant E141)

Intended use / Indications

• Anchoring of endoprostheses in primary and revision arthroplasty of hip, knee, ankle, shoulder and elbow

Clinical rationale and performance
COPAL® G+C delivers an initial high local antibiotic release that supports protection against bacterial colonisation of implants and adjacent tissue, particularly for gentamicin- and/or clindamycin-sensitive pathogens. The combination broadens the antimicrobial spectrum and may cover up to approximately 90% of pathogens typically associated with PJI. Clinical use includes prophylaxis in high‑risk primary arthroplasty patients, fracture-related arthroplasty after femoral neck fracture, and aseptic revision procedures.

Additional documents available

• Electronic Instructions for Use (eIFU)
• Summary of Safety and Clinical Performance (SSCP)

References

• Berberich CE, Josse J, Laurent F, Ferry T. Dual antibiotic loaded bone cement in patients at high infection risks in arthroplasty: Rationale of use for prophylaxis and scientific evidence. World J Orthop 2021; 12(3):119–28.
• Gehrke T., von Förster G., Frommelt L. Pharmacokinetic Study of a Gentamicin/Clindamicin Bone Cement Used in One-stage Revision Arthroplasty. In: Walenkamp GHIM et al., Bone Cements and Cementing Technique. Springer, 2001.
• Sanz-Ruiz P., Berberich C. Infection Risk-Adjusted Antibiotic Prophylaxis Strategies in Arthroplasty. OrthopRes Rev. 2020;12:89-96.
• Abdelaziz H. et al. Minimum 5 years' follow-up after gentamicin- and clindamycin-loaded PMMA cement in total joint arthroplasty. J Med Microbiol. 2019 Mar;68(3):475-479.
• Sprowson AP et al. The Fractured Hip Infection trial. Bone Joint J. 2016 Nov;98-B(11):1534-41.
• Savage P. et al. Arthroplasty infection rates in fractured neck of femur: single vs dual antibiotic cement. Ann R Coll Surg Engl. 2019 Sep;101(7):514-518.
• Tyas B. et al. Antibiotic resistance profiles of deep surgical site infections in hip hemiarthroplasty. J Bone Jt Infect. 2018;3(3):123-9.
• Sanz-Ruiz P. et al. Is Dual Antibiotic-Loaded Bone Cement More Effective and Cost-Efficient Than a Single Antibiotic-Loaded Bone Cement to Reduce the Risk of PJI in Aseptic Revision Knee Arthroplasty? J Arthroplasty. 2020 Dec;35(12):3724-3729.

Technical specifications

• Product name: COPAL® G+C
• Type: High-viscosity PMMA bone cement with dual antibiotics
• Antibiotic content: 1 g gentamicin + 1 g clindamycin (per unit)
• Radiopacity: Radiopaque formulation
• Colorant: Green (E141)
• Clinical application: Anchoring endoprostheses in hip, knee, ankle, shoulder, elbow (primary and revision arthroplasty)
• Therapeutic purpose: Local infection prophylaxis/management in arthroplasty with broad-spectrum coverage against common PJI pathogens
• Notable performance: Initial high local antibiotic release; combination may target up to ~90% of pathogens typically implicated in PJI