This clinical trial studies the clinical effectiveness of S53P4 bioactive glass (BAG) as a bacterial growth inhibiting bone graft substitute in a one-stage or two-stage surgical procedure for treatment of chronic long bone osteomyelitis.
In this prospective multicenter study, patients from two different university hospitals in the Netherlands were included. Treatment consisted of debridement surgery, implantation of S53P4-BAG, if necessary wound closure by a plastic surgeon and additional culture based systemic antibiotics. Primary outcome was eradication of infection based on clinical presentation, radiographic imaging and laboratory tests. Secondary analysis was performed on probable risk factors for treatment failure after S53P4-BAG implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.
Eradication of infection In clinical presentation
Based on the following Clinical Signs: \- Absence of a draining fistula, redness, swelling, pain and fever (\>38,5 degrees of celcius)
Time frame: 1-5 years follow-up
Absence of signs of chronic osteomyelitis on radiographic imaging (1/2)
Radiographic analysis of X-ray or CT images of the affected bone Based on a combination of 2 different infection paramaters Parameter 1: \- Bone destruction
Time frame: 1 - 5 years follow-up
Absence of signs of chronic osteomyelitis on radiographic imaging (2/2)
Radiographic analysis of X-ray or CT images of the affected bone Based on a combination of 2 different infection paramaters Parameter 2: \- Periostal reactions
Time frame: 1 - 5 years follow-up
Eradication of infection in blood sample analysis (1/3)
Based on a combination of 3 different infection parameters; parameter 1 is C-Reactive protein (\<10mg/L), collected from a venapuncture.
Time frame: 1 - 5 years follow-up
Eradication of infection in blood sample analysis (2/3)
Based on a combination of 3 different infection parameters; parameter 2 is Leukocyte count (\<11 x 10E9 cells/L); collected from a venapuncture.
Time frame: 1 - 5 years follow-up
Eradication of infection in blood sample analysis (3/3)
Based on a combination of 3 different infection parameters; parameter 3 is Erythrocyte Sedimantation Rate (\<22mm/hour) collected from a venapuncture.
Time frame: 1 - 5 years follow-up
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Complication registration
Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment
Time frame: 1-5 years follow-up