Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Results of Chronic Cavitary Long-bone Osteomyelitis Treatment Using S53P4 Bioactive Glass; a Multi-center Study

Conditions
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Osteomyelitis, Bone Infection, Non-Union Fracture, Bone Infection of Lower Leg, Bone Infection of Pelvis, Hip, or Femur

Intervention / Treatment
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* Device: S53P4 bioactive glass (BonAlive)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a clinical, radiographic and/or laboratory study confirmed chronic osteomyelitis of long bones Patients who are physically and mentally willing and able to comply with postoperative functional evaluation. Patients that can read and understand the Dutch language. Exclusion Criteria: Patients with an diabetic ulcer related chronic osteomyelitis Patients that are pregnant. Patients who are unwilling to cooperate with the study protocol and follow-up schedule. Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule. Patients with malignancy - active malignancy within last 1 year Patients known with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (severe osteoporosis requiring medication, Paget's disease, renal osteodystrophy,hypercalcemia ) or is immunologically suppressed, or receiving steroids in excess of physiologic dose. Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period. Patients with systemic or metabolic disorders leading to progressive bone deterioration Patients with other concurrent illnesses that are likely to affect their outcome such as all autoimmune diseases (including RA), sickle cell anaemia, systemic lupus erythematosus, psoriasis, not controlled type 1/2 diabetes or renal disease requiring dialysis. Patients with a known sensitivity to device materials Patients that are an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S53P4 BAG intervention group<br>Patients recruited and enrolled in study for treatment with S53P4 BAG | Device: S53P4 bioactive glass (BonAlive)<br>* Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.<br>* Other names: Bonalive bioactive glass;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 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. | 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. | 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. | 1 - 5 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication registration | Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment | 1-5 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioactive glass, S53P4 BAG, Bonalive, Chronic Osteomyelitis