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

• ClinicalTrials.gov Identifier: NCT03849014
• Recruitment Status: Completed
• First Posted: February 21, 2019
• Last Update Posted: April 27, 2021
• Sponsor: Kushtrim Grezda
• Collaborator: University Clinical Centre of Kosova
• Information provided by (Responsible Party): Kushtrim Grezda, University Clinical Centre of Kosova

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hip Fractures	Procedure: Dynamic Hip Screw; Procedure: Proximal Femoral Nail	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With Dynamic Hip Screw Versus Proximal Femoral Nail
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: December 1, 2019
• Actual Study Completion Date: June 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Kosovo

Qendra Klinike Universitare e Kosoves

Pristina, Kosovo

Sponsors and Collaborators

Kushtrim Grezda

University Clinical Centre of Kosova

Investigators

• Principal Investigator: Kushtrim Grezda, MD; University Clinical Centre of Kosova

More Information

• Responsible Party: Kushtrim Grezda, Principal Investigator, Clinical Research, University Clinical Centre of Kosova
• ClinicalTrials.gov Identifier: NCT03849014
• Other Study ID Numbers: KGrezda
• First Posted: February 21, 2019
• Last Update Posted: April 27, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by Kushtrim Grezda, University Clinical Centre of Kosova:

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

Additional relevant MeSH terms:

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