Hip Fractures
Conditions
Keywords
Hip fractures, Inflammatory response, Interleukin-6, Comparative study
Brief summary
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.
Interventions
PROCEDUREDynamic Hip Screw
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.
PROCEDUREProximal Femoral Nail
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.
Sponsors
University Clinical Centre of Kosova
Kushtrim Grezda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference of the level of IL-6 in operated patients. | 1 hour before and 24 hours after operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference of the level of D-dimer | 1 hour before and 24 hours after operation | The analysis will be performed immediately after the blood sample is collected. |
| The difference of the level of ESR | 1 hour before and 24 hours after operation | The analysis will be performed immediately after the blood sample is collected. |
| The difference of the length of operation | Intra-operatively | The stopwatch will be turned on from the incision until the end of the skin suture |
| The difference of the level of CRP in operated patients. | 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 analysis will be performed immediately after the blood sample is collected. |
| Blood loss | Levels of HB before and after surgery. Also the total volume of blood transfusion. | HB-balance method will be used |
| Complications after surgery | Within 1 month after surgery | All complications that might occur after surgery will be registered |
| Mortality rate | Within 1 month after surgery | The mortality of patients that might happen after surgery |
| The difference of the level of length of incision | After the wound closure | The measure will be made with centimeters (cm) |
Countries
Kosovo
Outcome results
None listed