Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis (NCT04945434) | Clinical Trial Compass
UnknownNot Applicable
Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis
78 participantsStarted 2011-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Eradication of infection In clinical presentation
Timeframe: 1-5 years follow-up
2
Absence of signs of chronic osteomyelitis on radiographic imaging (1/2)
Timeframe: 1 - 5 years follow-up
3
Absence of signs of chronic osteomyelitis on radiographic imaging (2/2)
Timeframe: 1 - 5 years follow-up
4
Eradication of infection in blood sample analysis (1/3)
Timeframe: 1 - 5 years follow-up
5
Eradication of infection in blood sample analysis (2/3)
Timeframe: 1 - 5 years follow-up
6
Eradication of infection in blood sample analysis (3/3)