Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04945434
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04945434
Study Brief:
Protocol Section:
NCT04945434