Calcium-Based, Antibiotic-Loaded Bone Substitute as an Implant Coating: A Pilot Clinical Study

Abstract

Background: Implant-related infections remain a major complication after orthopaedic surgery. Antibacterial coating of implants may prevent bacterial adhesion and biofilm formation. However, in spite of extensive preclinical research in the field, antibacterial coatings to protect orthopaedic implants in the clinical setting remain particularly few. The aim of the present study is to evaluate the safety of a calcium-based, antibiotic-loaded bone substitute as an antibacterial coating of cementless joint prosthesis.Methods: From March 2013 to August 2015, 20 consecutive patients scheduled for cementless or hybrid two-stage revision surgery for peri-prosthetic joint infection were included in this prospective, observational, pilot study. Cerament G or Cerament V, a gentamicin or vancomycin-loaded calcium-based resorbable bone substitute (60% calcium sulphate, 40% hydroxyapatite), was applied at surgery on the stem surface of hip (n=7) or knee (n=13) revision prosthesis. After surgery, all patients underwent clinical (HHS or KSS and SF-12 score), laboratory and radiographic evaluation at 3, 6 and 12 months and yearly thereafter.Results: At a minimum of 12 months follow-up, 19/20 (95%) patients showed no recurrence of infection and no signs of radiographic loosening of the stem. No adverse events were associated with the use of Cerament G or V.Conclusions: This is the first pilot clinical study on the short-term safety of using a calcium-based, gentamicin or vancomycin-loaded bone substitute as a surface coating on cementless prosthetic implants. If confirmed by larger studies and at longer follow-ups, these findings may open a new prospective to protect intra-operatively orthopedic implants from bacterial adhesion, through the use of resorbable, osteoconductive, antibiotic carriers.

Antibiotic Elution Characteristics and Pharmacokinetics of Gentamicin and Vancomycin from a Mineral Antibiotic Carrier: An in vivo Evaluation of 32 Clinical Cases

“…Accordingly, the plasma levels observed in this study were well below these levels and cannot be considered nephrotoxic or ototoxic. This finding agrees with other studies examining the same antibiotic carrier, confirming equally low plasma levels and/or no side-effects related to antibiotic toxicity 11 , 22 , 23 . However, other studies report potential toxic antibiotic levels when using local antibiotic eluting grafts 24 and special caution must be taken when a patient is suffering with concomitant renal failure 25 .…”

Doped Halloysite Nanotubes for Use in the 3D Printing of Medical Devices

“…Silicate-based systems [ 60 ] and bioglasses [ 61 ] have been studied for the treatment of chronic osteomyelitis. However, osteoconductive bioceramics (calcium sulfate, tricalcium phosphate or hydroxyapatite) or bioceramic composites infused with antibiotics combine antibiotic therapy with osteoconductive capabilities [ 62 , 63 , 64 ]. Their major advantage is they strongly bond with bone, fill bone voids, and will convert to hydroxyapatite that promotes osteogenesis at the defect site [ 65 , 66 ].…”

“…Our device can be fabricated to specifically fit each patient’s condition and site of infection ( Figure 10 ). Drug-doped HNTs can be printed into a single strand of biodegradable beads or disks (PLA or PCL) with customized features including a suite of antibiotics, different dosage levels, drug combinations such as anti-microbials and chemotherapeutics without disadvantages with systemic delivery systems [ 63 , 64 ]. Its use would result in a lower serum antibiotic concentration than that is usually associated with systemic administration, thereby reducing toxicity-related side-effects.…”

Biofilms in Periprosthetic Joint Infections: A Review of Diagnostic Modalities, Current Treatments, and Future Directions

“…114 Another alternative may include applying an antibiotic hydrogel coating to implants; a study evaluating one-stage revision arthroplasty with an implant coated with defensive antibacterial coating (DAC) hydrogel demonstrated a similar rate of infection recurrence compared with two-stage revision with significantly lower systemic antibiotic therapy and hospital length of stay. 115 A pilot study is being conducted evaluating calcium-based gentamicin or vancomycin-loaded bone substitute 116 with evidence of improved clearance of bacteria in a murine model. 117 Phosphatidylcholine coatings may also elute antibiotics and improve bacterial clearance in a mouse model of PJI 118 but further human studies are required.…”