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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849014
• Other study ID #: KGrezda
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2021
• Source: University Clinical Centre of Kosova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Kosovo	Qendra Klinike Universitare e Kosoves	Pristina

Sponsors (2)

Lead Sponsor	Collaborator
Kushtrim Grezda	University Clinical Centre of Kosova

Country where clinical trial is conducted

Kosovo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The difference of the level of length of incision	The measure will be made with centimeters (cm)	After the wound closure
Secondary	Blood loss	HB-balance method will be used	Levels of HB before and after surgery. Also the total volume of blood transfusion.
Secondary	Complications after surgery	All complications that might occur after surgery will be registered	Within 1 month after surgery
Secondary	Mortality rate	The mortality of patients that might happen after surgery	Within 1 month after surgery