bone infection
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study are scheduled to undergo osteomyelitis debridement surgery combined with implantation of BonAlive bioactive glass at MUMC+. ;Inclusion criteria: Subjects meeting all of the following criteria will be included in the study.;1. Patients with chronic (>12 weeks) osteomyelitis located in the distal tibia, distal fibula, ankle or foot. Or located in de distal radius, distal ulna, wrist or hand. 2. Patients who are scheduled to undergo osteomyelitis debridement surgery combined with implantation of BonAlive bioactive glass at MUMC+. 3. Patients that have normal contralateral bone, which will be used as an internal control. 4. Patients who accepted and signed the ethics committee approved informed consent before the first HR-pQCT scan. 5. Male and non-pregnant female patients between 18-70 years of age. 6. Patients who are physically and mentally able and willing to comply with the regulations of this study. 7. Patient can read and understand the Dutch language.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study.;1. Patients who are unwilling to cooperate with the study protocol and follow-up schedule. 2. Patients with chronic osteomyelitis associated with fracture in need of osteosynthesis surgery 3. 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. 4. Obese patients where obesity is severe enough to affect subject*s ability to perform activities of daily living (body mass index, kg/m2 > 40) 5. Patients with malignancy - active malignancy within last 1 year 6. 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, hypercalcaemia) or is immunologically suppressed, or receiving steroids in excess of physiologic dose. 7. Patients with systemic or metabolic disorders leading to progressive bone deterioration. 8. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g., steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs. 9. Patients with a known sensitivity to, specific antibiotics or radiation. 10. Patients under age of 18 and above age of 70 11. Females who wish to become pregnant before, during or after (up to two years) the course of their treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First objective of this study is assessment of bone healing capacity of Bonalive bioactive glass by High Resolution peripheral Quantitative Computed Tomography (HRpQCT). Several bone parameters will be calculated during longitudinal follow up (see section 5.1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Second objective of this study is the evaluation of bone strength based upon micro-finite element analysis (µFEA), calculated after HR-pQCT imaging. Bone strength will be evaluated using longitudinal µFEA outcomes of patients during follow up. Third objective of this study is to assess the improvement of patient related outcomes assessed at 6, 52 and 104 weeks after surgery. This is an addition to the patient satisfaction obtained in standard follow-up algorithm of chronic osteomyelitis treatment. Fourth objective of this study is to evaluate the infection eradication success of osteomyelitic bone defects reconstructed with BonAlive bioactive glass. This is an important outcome because the presence of an infection may influence the results of the HRpQCT scans, which makes these results no longer reliable. Absence of infection will be based upon clinical data, X-ray analysis and infection rates assessed in blood sample analysis, which belong to the standard follow-up algorithm of chronic osteomyelitis treatment. | — |
Countries
Netherlands
Outcome results
None listed