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| Name | Class |
|---|---|
| Klinar CRO | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Feasibility | Experimental | Device feasibility will be performed in this single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moment Tumour Hip Prothesis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse Events | Reliability of the procedure (adverse events occurring) | 6 Months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Toleratibily of the patients for the procedure. | 6 Months |
| Hip pain and function for 6 months after the procedure according to the MSTS scoring | Hip pain and function for 6 months after the procedure according to the MSTS scoring | 6 Months |
| Change in Quality of life | Determination of the change in quality of life from baseline to 6 month after the procedure | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Functional Parameters | Percent change in in functional parameters compared to baseline during the follow-up period. | 6 Months |
| Complications | Complications will be evaluated in patients with complications according to the Henderson classification. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University Faculty of Medicine | Ankara | Turkey (Türkiye) | ||||
| Hacettepe University Faculty of Medicine |
There i no plan to share IPD
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| ID | Term |
|---|---|
| D010146 | Pain |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| 6 Months |
| Procedure's Safety | Number of adverse event: observed adverse events (AE) with the help of radiographic evaluations and Examinations performed | 6 Months |
| Ankara |
| Turkey (Türkiye) |
| Pamukkale University Faculty of Medicine | Denizli | Turkey (Türkiye) |
| Eskişehir Osmangazi University Health Practice and Research Hospital | Eskişehir | Turkey (Türkiye) |
| Istanbul Göztepe Prof.Dr. Suleyman Yalcin City Hospital | Istanbul | Turkey (Türkiye) |
| Necmettin Erbakan University Meram Faculty of Medicine | Konya | Turkey (Türkiye) |
| Cumhuriyet University School of Medicine | Sivas | Turkey (Türkiye) |