Evaluation of a new hip replacement for bone tumors
Clinical Evaluation of Moment Tumor Hip Replacement Products Within the Scope of Substantial Clinical Trials
This study is testing a new hip replacement for people with bone tumors to see if it helps them move better and feel less pain after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Estas Tıbbi Mamülleri Medikal Industry-sponsored |
| Locations | 7 sites (Ankara and 6 other locations) |
| Trial ID | NCT05847868 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation focuses on the use of Moment Tumor Hip Replacement Products for patients with primary and secondary bone tumors in the proximal femur region. The study is a prospective cohort trial conducted across six centers, aiming to assess the functional mobility and pain levels of patients after receiving the prosthesis. Over a six-month period, patients will be monitored for complications and the overall clinical performance of the hip replacement. The goal is to enhance patient survival following wide resection surgeries and contribute valuable data to the medical literature.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-79 with severe pain or functional loss in the proximal femur due to bone tumors or related conditions.
Not a fit: Patients outside the age range of 18-79, pregnant or breastfeeding women, and those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and mobility for patients with bone tumors in the hip region.
How similar studies have performed: While similar approaches have been explored, this specific evaluation of the Moment Tumor Hip Replacement Products is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ankara and 6 other locations
- Gazi University Faculty of Medicine — Ankara, Turkey (Recruiting)
- Hacettepe University Faculty of Medicine — Ankara, Turkey (Recruiting)
- Pamukkale University Faculty of Medicine — Denizli, Turkey (Recruiting)
- Eskişehir Osmangazi University Health Practice and Research Hospital — Eskisehir, Turkey (Recruiting)
- Istanbul Göztepe Prof.Dr. Suleyman Yalcin City Hospital — Istanbul, Turkey (Recruiting)
- Necmettin Erbakan University Meram Faculty of Medicine — Konya, Turkey (Recruiting)
- Cumhuriyet University School of Medicine — Sivas, Turkey (Recruiting)
Study contacts
- Study coordinator: Mustafa Cetin
- Email: mustafa.cetin@estas.com.tr
- Phone: 0090534 461 72 58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.