Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With DHS Versus PFN
- Conditions
- Hip Fractures
- Interventions
- Procedure: Proximal Femoral NailProcedure: Dynamic Hip Screw
- Registration Number
- NCT03849014
- Lead Sponsor
- Kushtrim Grezda
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Proximal Femoral Nail Proximal Femoral Nail 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. Dynamic Hip Screw Dynamic Hip Screw 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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 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 level of length of incision After the wound closure The measure will be made with centimeters (cm)
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
Trial Locations
- Locations (1)
Qendra Klinike Universitare e Kosoves
Pristina, Kosovo