Efficacy and Safety of Antibiotic Impregnated Microporous Nanohydroxyapatite Beads for Chronic Osteomyelitis Treatment: A Multicenter, Open-Label, Prospective Cohort Study
Chittawee Jiamton,
Adinun Apivatgaroon,
Saree Aunaramwat,
Banchai Chawalitrujiwong,
Chaiwat Chuaychoosakoon,
Sitthiphong Suwannaphisit,
Choen Jirawison,
Chonlathan Iamsumang,
Pinkawas Kongmalai,
Pawaris Sukvanich,
Pongtep Na Nakorn,
Worawit Ongbumrungphan,
Pawin Rattanasumrit,
Suthee Tharakulphan,
Thanachai Thongtanworapat,
Faungchat Thammarakcharoen,
Autcharaporn Srion,
Jintamai Suwanprateeb,
Bancha Chernchujit
Affiliations
Chittawee Jiamton
Institute of Orthopaedics, Lerdsin Hospital, Silom Road, Bang Rak, Bangkok 10500, Thailand
Adinun Apivatgaroon
Department of Orthopaedics, Faculty of Medicine, Thammasat University, Paholyothin Road, Klong Nueng, Klong Luang, Pathum Thani 12121, Thailand
Saree Aunaramwat
Paholpolpayuhasena Hospital, Sangchuto Road, Pak Phraek, Mueang, Kanchanaburi 71000, Thailand
Department of Orthopedics, Faculty of Medicine, Srinakharinwirot University, Rangsit-Nakhon Nayok Road, Baan na, Ongkharak, Nakhon Nayok 26120, Thailand
Pawaris Sukvanich
Department of Orthopedics, Faculty of Medicine, Srinakharinwirot University, Rangsit-Nakhon Nayok Road, Baan na, Ongkharak, Nakhon Nayok 26120, Thailand
Pongtep Na Nakorn
Hatyai Hospital, Ratthakan, Tambon Hat Yai, Hat Yai, Songkhla 90110, Thailand
Worawit Ongbumrungphan
Bhumibol Adulyadej Hospital, Phahonyothin Road, Sai Mai, Bangkok 10220, Thailand
Pawin Rattanasumrit
Bhumibol Adulyadej Hospital, Phahonyothin Road, Sai Mai, Bangkok 10220, Thailand
Suthee Tharakulphan
Khon Kaen Hospital, Sri Chant Road, Nai Mueang, Mueang, Khon Kaen 40000, Thailand
Thanachai Thongtanworapat
Pathumtani Hospital, Lat Lum Kaeo Road, Bang Prok, Muang, Pathum Thani 12000, Thailand
Faungchat Thammarakcharoen
National Metal and Materials Technology Center (MTEC), National Science and Technology Development Agency (NSTDA), 111 Phahonyothin Road, Khlong Nueng, Khlong Luang, Pathum Thani 12120, Thailand
Autcharaporn Srion
National Metal and Materials Technology Center (MTEC), National Science and Technology Development Agency (NSTDA), 111 Phahonyothin Road, Khlong Nueng, Khlong Luang, Pathum Thani 12120, Thailand
Jintamai Suwanprateeb
National Metal and Materials Technology Center (MTEC), National Science and Technology Development Agency (NSTDA), 111 Phahonyothin Road, Khlong Nueng, Khlong Luang, Pathum Thani 12120, Thailand
Bancha Chernchujit
Department of Orthopaedics, Faculty of Medicine, Thammasat University, Paholyothin Road, Klong Nueng, Klong Luang, Pathum Thani 12121, Thailand
Chronic osteomyelitis is still a serious health problem that causes disabling conditions and has an impact on the quality of life. The objective of this study was to determine the clinical efficacy and safety of localized antibiotics delivery via impregnated microporous nanohydroxyapatite (nHA-ATB) beads for chronic osteomyelitis treatment. A total of 62 patients were enrolled in this study. After radical surgical debridement, the bone defect was filled with three types of antibiotics (vancomycin or gentamicin or fosfomycin) impregnated HA beads. The follow-up period was 48 weeks. It was found that the success rate was approximately 98% with a re-infection in only one patient. Quality of life of all patients after treatment improved significantly over time. Systemic exposure to vancomycin and gentamicin after beads implantation was limited and high local antibiotics concentrations were found in wound drainage fluid at 24, 48 and 72 h. Blood biochemistry measurements did not show any nephrotoxic or hepatotoxic effects. 20 adverse events were reported, but 90% of the events were resolved without having to remove the beads and the patients recovered. Satisfactory outcomes were observed in terms of success rate, quality of life and adverse effect. nHA-ATB beads impregnated by vancomycin or gentamicin or fosfomycin could potentially be employed as an alternative product of choice for localized antibiotics delivery in chronic osteomyelitis treatment.
