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The objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail.
The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture.
Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to the static mode.
Intertrochanteric fragility fractures are one of the most frequent fractures in the elderly . They produce great disability and complications in our patients and they are recognized worldwide as a major public health problem.
The treatment that presents the best results is surgical treatment, since it reduces the mortality of the patients and allows early loading . Thus, avoids secondary complications to the prostration state such as pneumonia, bedsores, pulmonary embolisms, among others.
Currently, the treatment that has shown the best clinical and biomechanical results is osteosynthesis with a cephalomedullary nail, which despite having good results is not free from complications such as implant failure, loss of femoral offset.
Changes are constantly made in the design and surgical techniques of these implants in order to decrease the rate of complications.
This study will particularly assess whether there is any difference in the complication rate between dynamic versus static lag screw modes.
Biomechanical studies that compare these two lag screw modes show that axial and lateral stiffness of the femur-nail construction is greater in static mode than in dynamic modes and the torsional stiffness is greater in dynamic mode than in static modes.
There are no studies comparing the clinical results of these two variants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lag screw with dynamic mode | Active Comparator | Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes |
|
| lag screw with static mode | Active Comparator | Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation. | Device | Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with dynamic lag screw as proximal fixation |
| Measure | Description | Time Frame |
|---|---|---|
| Implant failure | Rate of cut out , cut through. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Rate of Infection and Non Union. | 3 weeks, 3 months , 6 months |
| Offset | Changes in femoral offset | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pablo Suarez, MD | Contact | +56961572181 | pablosuarez088@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Traumatologico | Recruiting | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22439235 | Background | Kuzyk PR, Shah S, Zdero R, Olsen M, Waddell JP, Schemitsch EH. A biomechanical comparison of static versus dynamic lag screw modes for cephalomedullary nails used to fix unstable peritrochanteric fractures. J Trauma Acute Care Surg. 2012 Feb;72(2):E65-70. doi: 10.1097/ta.0b013e3182170823. | |
| 8020229 | Background |
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| Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation. | Device | Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with static lag screw as proximal fixation |
|
| Mahomed N, Harrington I, Kellam J, Maistrelli G, Hearn T, Vroemen J. Biomechanical analysis of the Gamma nail and sliding hip screw. Clin Orthop Relat Res. 1994 Jul;(304):280-8. |
| 29166235 | Background | Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available. |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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