A multicenter study of localized antibiotic released hydroxyapatite beads for bone infection treatment in Thailand

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20170123002

Enrollment

Registered

2017-01-23

Start date

2018-10-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The ability of new antibiotics impregnated hydroxyapatite beads in treatment of chronic osteomyelitis will be evaluated together with the bone fusion properties. Antibiotics beads Osteomyelitis Hydroxyapatite

Interventions

The infected bone area is cleaned. Debridement with management of resultant dead space, removal of all foreign bodies and, if necessary, stabilization of bone are then carried out. Antibiotics impreg

Experimental Device

Antibiotics impregnated hydroxyapatite beads

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Patients who are diagnosed as chronic osteomyelitis by having bone infection for more than 6 weeks, having dead bone and bone reparative reaction. -Cierny & Mader anatomical staging class A and B.

Exclusion criteria

Exclusion criteria: -Patients who are allergy to vancomycin, gentamicin and fosfomycin antibiotics -Patient who need ongoing antibiotics treatment i.e melioidosis. -Patients who have renal insufficiency or renal failure (eGFR < 30 ml/min/m2 by Cockcroft-Gault equation (CG)) -HIV patients and/or CD4 < 350 cell/ mm3 -Patients who are pregnant and lactation -DM patients or having HbA1C > 8% at 3 months prior to enrollment. -Patients -Patients who have multiple active injuries or head injuries -Immunocompromided patient or having history of using immunosuppressive drug or corticosteroid equivalent to Prednisolone > 10 mg per day for longer than 2 wks -Patients having history of using folk medicine containing steroids -Patients who have malignancy at site of infection -Patients who use or having history of using narcotic drugs or using syringe with others. -Patient who were infected with antibiotic-resistant gram-negative bacteria

Design outcomes

Primary

Measure	Time frame
Success rate of antibiotics impregnated hydroxyapatite beads 12 wks Clinical evaluation, Blood chemistry, X-ray,Reinfection rate of antibiotics impregnated hydroxyapatite beads 24 wks Clinical evaluation, Blood chemistry, X-ray	—

Secondary

Measure	Time frame
Quality of life Immediate Postop, 6 wks, 12 wks, 24 wks Questionaire,Time to discharge 2 wks, 4 wks, 6 wks Chart review	—

Countries

Thailand

Contacts

Public ContactJintamai Suwanprateeb

National Metal and Materials Technology Center

jintamai@mtec.or.th025646500

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026