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The purpose of this study is to determine whether this new intramedullary fixation is effective in the treatment of intertrochanteric fracture.
With the progress of aging society, elderly patients with intertrochanteric fractures were occurred more and more. The best recommend treatment is surgical treatment of intramedullary fixation. However, existing methods of intramedullary fixation could not be restored the integrated interior support, and it will occur early hip varus. Meanwhile, the varus deformity will no longer develop if the two ends contact with wach other. This new intramedullary fixation device can overcome the existing shortage of intramedullary fixation devices and supporting the inside of the problem. It can prompting the fracture site to obtain a stronger initial stability, improve fracture healing rate, reduce the incidence of varus and allow patients with early weight-bearing walking.
This new type of intramedullary fixation of intertrochanteric fractures of devices, including a proximal femoral anatomy and adapt to proximal femoral nail, proximal femoral nail through the femoral head and distal femur compression screw locking screw, its main features are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unstable intertrochanteric fracture fixed with novel nail | Experimental | AO/OTA A2 fracture fixed with novel nail |
|
| unstable intertrochanteric fracture fixed with PFNA | Experimental | AO/OTA A2 fracture fixed with PFNA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| new type of intramedullary nail | Device | This is a new fixation treat for intertrochanteric fracture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative quality of life score | SF-36 PCS | preoperative, six months and one year postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| rate of fracture healing at three months | fracture healing condition was checked by radiological examination. | three months postoperative |
| rate of femoral medialization | femoral medialization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tang Peifu, Dr. | Contact | 861099638101 | pftang301@126.com | |
| Shen Jing, Dr. | Contact | 8613718623511 | orthjing@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Tang Peifu | Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedics department; The General Hospital of the People's Liberation Army | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38772935 | Derived | Nie S, Li J, Liu X, Liu J, Wu X, Tang P, Zhao Y, Li M, Zhang L. The clinical efficacy of Medial Sustain Nail(MSN) and Proximal femoral nail anti-rotation(PFNA) for fixation of medial comminuted trochanteric fractures: a prospective randomized controlled trial. Int Orthop. 2024 Aug;48(8):2189-2200. doi: 10.1007/s00264-024-06220-6. Epub 2024 May 21. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| The intramedullary nail of PFNA | Device | It was used very common in treat with intertrochanteric fracture. |
|
|
| one year postoperative |
| collodiaphyseal angle | collodiaphyseal angle | one year postoperative |
| weight bearing | time of weight bearing | perioperation |
| rate of patient satisfaction with treatment | 1-year VAS satisfaction | one year postoperative |
| Hip function score | OHS | preoperative, six months and one year postoperative |
| time of surgical during | The time from the beginning to the end of the surgery | Perioperative |
| fluoroscopy time | Duration of fluoroscopy | intraoperative |
| rate of complications related to implant | cut out, nonunion, implant breakage/failure, infection | one year |
| D007869 |
| Leg Injuries |