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Clinical Trials/NCT03849014
NCT03849014
Completed
Not Applicable

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

Kushtrim Grezda1 site in 1 country60 target enrollmentJanuary 1, 2019
ConditionsHip Fractures

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
Kushtrim Grezda
Enrollment
60
Locations
1
Primary Endpoint
The difference of the level of IL-6 in operated patients.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
June 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kushtrim Grezda
Responsible Party
Sponsor Investigator
Principal Investigator

Kushtrim Grezda

Principal Investigator, Clinical Research

University Clinical Centre of Kosova

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

Outcomes

Primary Outcomes

The difference of the level of IL-6 in operated patients.

Time Frame: 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 Outcomes

  • The difference of the length of operation(Intra-operatively)
  • 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 difference of the level of D-dimer(1 hour before and 24 hours after operation)
  • The difference of the level of ESR(1 hour before and 24 hours after operation)
  • The difference of the level of length of incision(After the wound closure)
  • Blood loss(Levels of HB before and after surgery. Also the total volume of blood transfusion.)
  • Complications after surgery(Within 1 month after surgery)
  • Mortality rate(Within 1 month after surgery)

Study Sites (1)

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