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:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT05847868
Eligibility Criteria:
Inclusion Criteria:
* Adults of both sexes aged 18-79 years
* For patients with bone loss, fractures, pseudarthrosis due to primary-secondary metastases in the hip femoral region, patients belonging to one or more of the following groups
* Patients with or with bone resections due to infection
* Patients with unsuccessful femoral component applications
* Patients in need of long-term stabilization of major bone defects caused by fractures with major and irreversible bone loss, periprosthetic fractures, traumatic non-tumor conditions affecting the trunks of the long bones, and comminuted fractures
* Patients with severe pain and loss of function in the proximal femoral region
* Patients with incompetence of the upper end of the femur or femoral neck fracture in hip replacement revisions.
* Have sufficient mental and physical capacity to sign the informed consent form for the procedure
Exclusion Criteria:
* Be under the age of 18 and over the age of 79
* Pregnancy
* Breastfeeding
* Patients with bone tumors near the implant
* Patients with acute or chronic infections (local or systemic) that reduce the adhesion resistance of the implant.
* Patients with defective bone structures that may prevent proper fixation of the implant and severe deterioration or axial deviation affecting bone quality
* Patients with inadequate bone quantity and quality as a result of osteoporosis
* Patients with underdeveloped skeletal structure
* Patients with vascular and neuromuscular disorders or muscular dystrophy and advanced muscle atrophy
* Patients with impaired blood flow caused by vascular changes due to previous surgical procedure, alcohol use, etc.
* Patients with more than expected implant overload due to obesity and/or vigorous physical activity or strain (such as sports, activities requiring physical activity)
* Patients with inflammatory degenerative joint disease
* Patients with pathologies that prevent surgical intervention
* Patients whose general condition is not good and who cannot handle anesthesia
* Patients who are uncoordinated or unwilling to operate, or who cannot follow instructions
* Patients with mental retardation who do not or cannot comply with post-operative care instructions
* Patients with neuropathic osteoarthropathy (charcot joint) joint disease
* Patients with multiple organ failure
* Patients with sepsis
* Patients with syndromes or concomitant diseases that may adversely affect the evaluation of patients due to its systematic involvement.
* Patients whose follow-up is not clinically or ethically appropriate due to complications that may develop during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT05847868
Study Brief:
Protocol Section:
NCT05847868