Clinical Evaluation of Moment Tumor Hip Replacement Products (KRIOS)
Primary and Secondary Bone Tumor in the Proximal Femur Region
About this trial
This is an interventional supportive care trial for Primary and Secondary Bone Tumor in the Proximal Femur Region focused on measuring hip, pain, fracture, inability, proximal
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
Sites / Locations
- Gazi University Faculty of MedicineRecruiting
- Hacettepe University Faculty of MedicineRecruiting
- Pamukkale University Faculty of MedicineRecruiting
- Eskişehir Osmangazi University Health Practice and Research HospitalRecruiting
- Istanbul Göztepe Prof.Dr. Suleyman Yalcin City HospitalRecruiting
- Necmettin Erbakan University Meram Faculty of MedicineRecruiting
- Cumhuriyet University School of MedicineRecruiting
Arms of the Study
Arm 1
Experimental
Device Feasibility
Device feasibility will be performed in this single arm study.