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

NCT ID: NCT03849014

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dynamic Hip Screw

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Proximal Femoral Nail

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Clinical Centre of Kosova

OTHER

Sponsor Role: collaborator

Kushtrim Grezda

OTHER

Sponsor Role: lead

Responsible Party

Kushtrim Grezda

Principal Investigator, Clinical Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kushtrim Grezda, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinical Centre of Kosova

Locations

Qendra Klinike Universitare e Kosoves

Pristina, , Kosovo

Countries

Kosovo

Other Identifiers

KGrezda

Identifier Type: -

Identifier Source: org_study_id