Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With DHS Versus PFN
Primary Purpose
Hip Fractures
Status
Completed
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Dynamic Hip Screw
Proximal Femoral Nail
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Hip fractures, Inflammatory response, Interleukin-6, Comparative study
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
Sites / Locations
- Qendra Klinike Universitare e Kosoves
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dynamic Hip Screw
Proximal Femoral Nail
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The difference of the level of CRP in operated patients.
The analysis will be performed immediately after the blood sample is collected.
The difference of the level of D-dimer
The analysis will be performed immediately after the blood sample is collected.
The difference of the level of ESR
The analysis will be performed immediately after the blood sample is collected.
The difference of the length of operation
The stopwatch will be turned on from the incision until the end of the skin suture
The difference of the level of length of incision
The measure will be made with centimeters (cm)
Blood loss
HB-balance method will be used
Complications after surgery
All complications that might occur after surgery will be registered
Mortality rate
The mortality of patients that might happen after surgery
Full Information
NCT ID
NCT03849014
First Posted
January 17, 2019
Last Updated
April 26, 2021
Sponsor
Kushtrim Grezda
Collaborators
University Clinical Centre of Kosova
1. Study Identification
Unique Protocol Identification Number
NCT03849014
Brief Title
Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With DHS Versus PFN
Official Title
Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With Dynamic Hip Screw Versus Proximal Femoral Nail
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kushtrim Grezda
Collaborators
University Clinical Centre of Kosova
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip fractures, Inflammatory response, Interleukin-6, Comparative study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dynamic Hip Screw
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Proximal Femoral Nail
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dynamic Hip Screw
Intervention Description
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
Intervention Name(s)
Proximal Femoral Nail
Intervention Description
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 Outcome Measure Information:
Title
The difference of the level of IL-6 in operated patients.
Description
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.
Time Frame
1 hour before and 24 hours after operation
Secondary Outcome Measure Information:
Title
The difference of the level of CRP in operated patients.
Description
The analysis will be performed immediately after the blood sample is collected.
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
Title
The difference of the level of D-dimer
Description
The analysis will be performed immediately after the blood sample is collected.
Time Frame
1 hour before and 24 hours after operation
Title
The difference of the level of ESR
Description
The analysis will be performed immediately after the blood sample is collected.
Time Frame
1 hour before and 24 hours after operation
Title
The difference of the length of operation
Description
The stopwatch will be turned on from the incision until the end of the skin suture
Time Frame
Intra-operatively
Title
The difference of the level of length of incision
Description
The measure will be made with centimeters (cm)
Time Frame
After the wound closure
Title
Blood loss
Description
HB-balance method will be used
Time Frame
Levels of HB before and after surgery. Also the total volume of blood transfusion.
Title
Complications after surgery
Description
All complications that might occur after surgery will be registered
Time Frame
Within 1 month after surgery
Title
Mortality rate
Description
The mortality of patients that might happen after surgery
Time Frame
Within 1 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kushtrim Grezda, MD
Organizational Affiliation
University Clinical Centre of Kosova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qendra Klinike Universitare e Kosoves
City
Pristina
Country
Kosovo
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With DHS Versus PFN
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