Clinical trial NCT03849014: Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With DHS Versus PFN
Official title: Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With Dynamic Hip Screw Versus Proximal Femoral Nail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Hip fractures
Inflammatory response
Interleukin-6
Comparative study
Lead sponsor: University Clinical Centre of Kosova
Sponsor class: OTHER
Collaborators: name: University Clinical Centre of Kosova
First posted: 2019-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The difference of the level of IL-6 in operated patients.
timeFrame: 1 hour before and 24 hours after operation
Secondary outcomes:
measure: The difference of the level of CRP in operated patients.
timeFrame: 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
measure: The difference of the level of D-dimer
timeFrame: 1 hour before and 24 hours after operation
measure: The difference of the level of ESR
timeFrame: 1 hour before and 24 hours after operation
measure: The difference of the length of operation
timeFrame: Intra-operatively
measure: The difference of the level of length of incision
timeFrame: After the wound closure
measure: Blood loss
timeFrame: Levels of HB before and after surgery. Also the total volume of blood transfusion.
measure: Complications after surgery
timeFrame: Within 1 month after surgery
measure: Mortality rate
timeFrame: Within 1 month after surgery
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Qendra Klinike Universitare e Kosoves
Study officials:
affiliation: University Clinical Centre of Kosova
name: Kushtrim Grezda, MD
role: PRINCIPAL_INVESTIGATOR
References: