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Completed

NCT Number: NCT03849014

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

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qendra Klinike Universitare e Kosoves

Pristina, Kosovo

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. The difference of the level of CRP in operated patients.

    Time frame: 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 analysis will be performed immediately after the blood sample is collected.

  2. The difference of the level of D-dimer

    Time frame: 1 hour before and 24 hours after operation

    The analysis will be performed immediately after the blood sample is collected.

  3. The difference of the level of ESR

    Time frame: 1 hour before and 24 hours after operation

    The analysis will be performed immediately after the blood sample is collected.

  4. The difference of the length of operation

    Time frame: Intra-operatively

    The stopwatch will be turned on from the incision until the end of the skin suture

  5. The difference of the level of length of incision

    Time frame: After the wound closure

    The measure will be made with centimeters (cm)

  6. Blood loss

    Time frame: Levels of HB before and after surgery. Also the total volume of blood transfusion.

    HB-balance method will be used

  7. Complications after surgery

    Time frame: Within 1 month after surgery

    All complications that might occur after surgery will be registered

  8. Mortality rate

    Time frame: Within 1 month after surgery

    The mortality of patients that might happen after surgery

Sponsors and collaborators

Lead sponsor

Kushtrim Grezda

Other

Collaborators

  • University Clinical Centre of Kosova

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 21, 2019
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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