Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03849014
Other study ID # KGrezda
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date June 1, 2020

Study information

Verified date April 2021
Source University Clinical Centre of Kosova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Kosovo Qendra Klinike Universitare e Kosoves Pristina

Sponsors (2)

Lead Sponsor Collaborator
Kushtrim Grezda University Clinical Centre of Kosova

Country where clinical trial is conducted

Kosovo, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The difference of the level of CRP in operated patients. The analysis will be performed immediately after the blood sample is collected. 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
Secondary The difference of the level of D-dimer The analysis will be performed immediately after the blood sample is collected. 1 hour before and 24 hours after operation
Secondary The difference of the level of ESR The analysis will be performed immediately after the blood sample is collected. 1 hour before and 24 hours after operation
Secondary The difference of the length of operation The stopwatch will be turned on from the incision until the end of the skin suture Intra-operatively
Secondary The difference of the level of length of incision The measure will be made with centimeters (cm) After the wound closure
Secondary Blood loss HB-balance method will be used Levels of HB before and after surgery. Also the total volume of blood transfusion.
Secondary Complications after surgery All complications that might occur after surgery will be registered Within 1 month after surgery
Secondary Mortality rate The mortality of patients that might happen after surgery Within 1 month after surgery
See also
  Status Clinical Trial Phase
Completed NCT02507609 - Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium N/A
Completed NCT03906864 - Care Pathway for Sub-acute Hip Rehabilitation N/A
Recruiting NCT04063891 - Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients N/A
Completed NCT05039879 - Life Improving Factors After a Hip Fracture
Not yet recruiting NCT03887494 - Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY) N/A
Terminated NCT03065101 - Trigen InterTAN vs Sliding Hip Screw RCT N/A
Completed NCT03545347 - Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture. Phase 2
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05971173 - Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery Early Phase 1
Active, not recruiting NCT04957251 - Anterior vs Posterior Approach for Hip Hemiarthroplasty N/A
Terminated NCT04372966 - Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures N/A
Withdrawn NCT05030688 - Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty N/A
Completed NCT04424186 - 'Rehabilitation for Life' N/A
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Withdrawn NCT05518279 - Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures Phase 3
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Active, not recruiting NCT02247791 - Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty N/A
Completed NCT00746876 - Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. N/A
Completed NCT00058864 - The HIP Impact Protection Program (HIP PRO) N/A