Clinical Evaluation of Moment Tumor Hip Replacement Products

Trial Title: Clinical Evaluation of Moment Tumor Hip Replacement Products

NCT ID: NCT05847868

Condition: Primary and Secondary Bone Tumor in the Proximal Femur Region

Conditions: Official terms:
Bone Neoplasms

Conditions: Keywords:
hip
pain
fracture
inability
proximal

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Moment Tumour Hip Prothesis
Description: In the case of irreversible bone loss due to bone tumors, large and multi-part fractures, and pseudarthrosis in the proximal region of the femur bone, the defective bone area is removed and implants made of artificial materials are placed in order to replace the integrity of the bone. In addition, implant applications are made to the proximal femur region for the purpose of revision arthroplasty, which is typically replaced by total hip prosthesis depending on the wear condition. In this way, the bone integrity will be preserved, long-term stabilization will be provided to the patient and existing pain will be eliminated. Moment Tumor Hip Replacement Systems consist of proximal main body, extension pieces and intramedullary stems. Components are available in a variety of sizes to meet anatomical requirements and surgeon needs.
Arm group label: Device Feasibility

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 79 Years

Healthy volunteers: No

Locations:

Facility:
Name: Gazi University Faculty of Medicine

Address:
City: Ankara
Country: Turkey

Status: Recruiting

Contact:
Last name: Sefik Murat Arıkan

Facility:
Name: Hacettepe University Faculty of Medicine

Address:
City: Ankara
Country: Turkey

Status: Recruiting

Contact:
Last name: Mehmet Ayvaz

Facility:
Name: Pamukkale University Faculty of Medicine

Address:
City: Denizli
Country: Turkey

Status: Recruiting

Contact:
Last name: Ahmet Nadir Aydemir

Facility:
Name: Eskişehir Osmangazi University Health Practice and Research Hospital

Address:
City: Eskisehir
Country: Turkey

Status: Recruiting

Contact:
Last name: Ulukan Inan

Facility:
Name: Istanbul Göztepe Prof.Dr. Suleyman Yalcin City Hospital

Address:
City: Istanbul
Country: Turkey

Status: Recruiting

Contact:
Last name: Korhan Ozkan

Facility:
Name: Necmettin Erbakan University Meram Faculty of Medicine

Address:
City: Konya
Country: Turkey

Status: Recruiting

Contact:
Last name: Tahsin Sami Çolak

Facility:
Name: Cumhuriyet University School of Medicine

Address:
City: Sivas
Country: Turkey

Status: Recruiting

Contact:
Last name: Zekeriya Oztemur

Start date: March 16, 2023

Completion date: August 2025

Lead sponsor:
Agency: Estas Tıbbi Mamülleri Medikal
Agency class: Industry

Collaborator:
Agency: Klinar CRO
Agency class: Other

Source: Estas Tıbbi Mamülleri Medikal

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05847868