Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With DHS Versus PFN

Study Overview
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Brief Summary
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Hip fractures are one of the most frequent fractures in older adults. There is still controversy which surgical strategy is the best option for treatment of hip fractures especially trochanteric region fractures. Surgical intervention that follows hip fracture induces biochemical, physiological and fibrinolytic changes that are so-called second hit phenomenon which trigger systemic inflammatory response syndrome. The investigators are aiming to study this phenomenon after two different surgical procedures and help surgeons in everyday practice to choose the most suitable surgical treatment for patients with trochanteric region fracture and give the scientific community more evidence which methods is better since there is still controversy.

Official Title
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Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With Dynamic Hip Screw Versus Proximal Femoral Nail

Conditions
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Hip Fractures

Intervention / Treatment
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* Procedure: Dynamic Hip Screw
* Procedure: Proximal Femoral Nail


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with trochanteric region fractures AO/OTA 31.A1-31.A2 Time from fracture till surgery up to 1 week American Society of Anesthesiologists Classification (ASA) I-III Willing to participate Exclusion Criteria: Polytrauma patients Open fractures Existing local or systemic infection Pre-existing coagulatory disorder Existing malignancy Corticosteroid use Systemic inflammatory disease Voluntary withdraws of the patient

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dynamic Hip Screw<br>Dynamic Hip Screw is used for internal fixation of fractures of the certain types of hip fractures. The implant assembly consisting of a lag screw, a side plate, and cortical screws that fix the side plate to the proximal femoral shaft. | Procedure: Dynamic Hip Screw<br>* Dynamic Hip Screw fixation: Fracture will be reduced under image intensifier. The incision will be made 7-10 cm with a lateral approach. The fascia lata will be incised and the vastus lateralis muscle will be splited along the axis of the femur, without stripping the periosteum. A135° angle guide will be inserted in the lower half of the femoral neck. The barrel of the plate will be guided to the hip screw by direct palpation to minimize the soft-tissue injury. After the insertion of the cortical screw, soft tissue will be protected with 4.5mm drill sleeve during drilling and tapping.<br>|
| Active Comparator: Proximal Femoral Nail<br>The Proximal Femoral Nail offers osteosynthesis for the several types of hip fractures. It consists of an anatomically curved nail, double neck screw, and two locking screws for distal end. | Procedure: Proximal Femoral Nail<br>* Proximal Femoral Nail fixation: Fracture will be reduced under image intensifier. The incision 2-3 cm with a lateral approach that extended from the cranial part to the tip of the greater trochanter. After palpating the greater trochanter tip, the nail will be then introduced manually into the femoral shaft. The guide wire of the anti-rotational hip blade then introduced. The hip blade should be introduced in the direction of the lower half of the femoral neck. Drilling will be performed under soft-tissue protection with a retractor. The blade will be inserted, and a distal static locking screw and end cap will be inserted under soft tissue protection with a drill sleeve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of the level of IL-6 in operated patients. | The blood will be collected and after that centrifuged and then stored in -20 grade celsius. The analysis of each sample will be performed no later than 3 months. | 1 hour before and 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of the level of CRP in operated patients. | The analysis will be performed immediately after the blood sample is collected. | 1 hour before and 24 hours after operation. Length of operation, length of incision, blood loss perioperatively. Complication and mortality rate within 1 month after OP | 
| The difference of the level of D-dimer | The analysis will be performed immediately after the blood sample is collected. | 1 hour before and 24 hours after operation | 
| The difference of the level of ESR | The analysis will be performed immediately after the blood sample is collected. | 1 hour before and 24 hours after operation | 
| The difference of the length of operation | The stopwatch will be turned on from the incision until the end of the skin suture | Intra-operatively | 
| The difference of the level of length of incision | The measure will be made with centimeters (cm) | After the wound closure | 
| Blood loss | HB-balance method will be used | Levels of HB before and after surgery. Also the total volume of blood transfusion. | 
| Complications after surgery | All complications that might occur after surgery will be registered | Within 1 month after surgery | 
| Mortality rate | The mortality of patients that might happen after surgery | Within 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip fractures, Inflammatory response, Interleukin-6, Comparative study