Clinical Evaluation of Moment Tumor Hip Replacement Products (NCT05847868) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of Moment Tumor Hip Replacement Products
Turkey (Türkiye)42 participantsStarted 2023-03-16
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Adverse Events
Timeframe: 6 Months
2
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: 6 Months
3
Hip pain and function for 6 months after the procedure according to the MSTS scoring