Clinical Evaluation of Moment Tumor Hip Replacement Products (KRIOS)

Estas Medikal

Status

Completed

Conditions

Primary and Secondary Bone Tumor in the Proximal Femur Region

Treatments

Device: Moment Tumour Hip Prothesis

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05847868

K-BE001-KRIOS

Details and patient eligibility

About

The aim is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the Moment Tumor Hip Replacement Products used.

Full description

This study is a 6-center, prospective local medical device clinical trial. Trial period is 6 months. Patient recruitment will continue until the target sample number determined by the power analysis is reached. Since the application is surgical, it is within the scope of a one-time application. The patients will be followed for 6 months from the day of surgery. The study was designed as a prospective cohort study planned to be cross-sectional. The aim of this study is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the Moment Tumor Hip Replacement Products used and to contribute to the medical literature on proximal femoral resection prosthesis as a result of the study.

Enrollment

42 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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