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

NCT03849014 | Completed

• 1 other identifier: KGrezda
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Keywords

Hip fractures; Inflammatory response; Interleukin-6; Comparative study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 length of operation

  Intra-operatively

• The difference of the level of length of incision

  After the wound closure

Study Arms (2)

Dynamic Hip Screw

ACTIVE COMPARATOR

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

Proximal Femoral Nail

ACTIVE COMPARATOR

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

Interventions

Dynamic Hip Screw PROCEDURE

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.

Dynamic Hip Screw

Proximal Femoral Nail PROCEDURE

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.

Proximal Femoral Nail

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kushtrim Grezda: lead
• University Clinical Centre of Kosova: collaborator

Study Sites (1)

Qendra Klinike Universitare e Kosoves

Pristina, Kosovo

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Kushtrim Grezda, MD

  University Clinical Centre of Kosova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Research

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 21, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

KO (1)