Clinical trial NCT05847868: Clinical Evaluation of Moment Tumor Hip Replacement Products
Official title: Clinical Evaluation of Moment Tumor Hip Replacement Products Within the Scope of Substantial Clinical Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary and Secondary Bone Tumor in the Proximal Femur Region
Keywords: hip
pain
fracture
inability
proximal
Lead sponsor: Estas Tıbbi Mamülleri Medikal
Sponsor class: INDUSTRY
Collaborators: name: Klinar CRO
First posted: 2023-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Rate of Adverse Events
timeFrame: 6 Months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 Months
measure: Hip pain and function for 6 months after the procedure according to the MSTS scoring
timeFrame: 6 Months
measure: Change in Quality of life
timeFrame: 6 Months
Secondary outcomes:
measure: Improvement in Functional Parameters
timeFrame: 6 Months
measure: Complications
timeFrame: 6 Months
measure: Procedure's Safety
timeFrame: 6 Months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine
city: Denizli
country: Turkey
facility: Pamukkale University Faculty of Medicine
city: Eskisehir
country: Turkey
facility: Eskişehir Osmangazi University Health Practice and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Göztepe Prof.Dr. Suleyman Yalcin City Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Faculty of Medicine
city: Sivas
country: Turkey
facility: Cumhuriyet University School of Medicine
Study officials:
References: