Prospective longitudinal outcome study assessing the use of BonAlive bioactive glass for attaining eradication of osteomyelitis and stimulation of bone healing in patients requiring surgery in osteomyelitic bone defects.
- Conditions
- bone infectionosteomyelitis100040181000595910005944
- Registration Number
- NL-OMON46331
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Patients eligible for inclusion in this study are scheduled to undergo osteomyelitis debridement surgery combined with implantation of BonAlive bioactive glass at MUMC+. ;
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.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>First objective of this study is assessment of bone healing capacity of<br /><br>Bonalive bioactive glass by High Resolution peripheral Quantitative Computed<br /><br>Tomography (HRpQCT). Several bone parameters will be calculated during<br /><br>longitudinal follow up (see section 5.1). </p><br>
- Secondary Outcome Measures
Name Time Method