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

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Procedure: Dynamic Hip Screw; Procedure: Proximal Femoral Nail

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kosovo
  • Pristina, Kosovo
    • Qendra Klinike Universitare e Kosoves

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: Dynamic 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.
ACTIVE_COMPARATOR: 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.	Procedure: Proximal 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kushtrim Grezda
• Collaborators: University Clinical Centre of Kosova
• Investigators: Principal Investigator: Kushtrim Grezda, MD, University Clinical Centre of Kosova

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (ACTUAL): February 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Hip fractures; Inflammatory response; Comparative study; Interleukin-6
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: KGrezda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No