Bone Infection, Bone Infection of Lower Leg, Bone Infection of Pelvis, Hip, or Femur, Non-Union Fracture, Osteomyelitis
Conditions
Keywords
Bioactive glass, S53P4 BAG, Bonalive, Chronic Osteomyelitis
Brief summary
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
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.
Interventions
DEVICES53P4 bioactive glass (BonAlive)
Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.
Sponsors
University Medical Center Groningen
Academisch Ziekenhuis Maastricht
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of signs of chronic osteomyelitis on radiographic imaging (2/2) | 1 - 5 years follow-up | 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 |
| Eradication of infection In clinical presentation | 1-5 years follow-up | Based on the following Clinical Signs: \- Absence of a draining fistula, redness, swelling, pain and fever (\>38,5 degrees of celcius) |
| Absence of signs of chronic osteomyelitis on radiographic imaging (1/2) | 1 - 5 years follow-up | 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 |
| Eradication of infection in blood sample analysis (3/3) | 1 - 5 years follow-up | Based on a combination of 3 different infection parameters; parameter 3 is Erythrocyte Sedimantation Rate (\<22mm/hour) collected from a venapuncture. |
| Eradication of infection in blood sample analysis (1/3) | 1 - 5 years follow-up | Based on a combination of 3 different infection parameters; parameter 1 is C-Reactive protein (\<10mg/L), collected from a venapuncture. |
| Eradication of infection in blood sample analysis (2/3) | 1 - 5 years follow-up | Based on a combination of 3 different infection parameters; parameter 2 is Leukocyte count (\<11 x 10E9 cells/L); collected from a venapuncture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication registration | 1-5 years follow-up | Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Identification of possible risk factors for failure (8/10) | Per-operative value (not time related) | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 8: \- One stage vs. Two stage surgical procedure (number of patients) |
| Identification of possible risk factors for failure (1/10) | Pre-operative value (not time related) | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 1: \- Age at sugery (Years) |
| Identification of possible risk factors for failure (10/10) | 1-5 years follow-up | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 10: \- Complications (number of patients) |
| Identification of possible risk factors for failure (9/10) | Per-operative value (not time related) | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 9: \- Closure of wound by a plastic surgeon (Yes/No) |
| Identification of possible risk factors for failure (2/10) | Pre-operative value (not time related) | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 2: \- Gender (M/F) |
| Identification of possible risk factors for failure (3/10) | Pre-operative value (not time related) | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 3: \- BMI (kg/m2) |
| Identification of possible risk factors for failure (4/10) | 1-5 years follow-up | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 4: \- Smoking (Yes/No) |
| Identification of possible risk factors for failure (5/10) | Pre-operative value (not time related) | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 5: \- Preoperative Cierny-Mader classification (1/2/3/4) |
| Identification of possible risk factors for failure (6/10) | Pre-operative value (not time related) | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 6: \- Presence of a preoperative fistula (number of patients) |
| Identification of possible risk factors for failure (7/10) | Postoperative value (not time related) | We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 7: \- Mono- vs. Polybacterial peroperative culture (number of patients) |
Outcome results
None listed