Hip FracturesNCT03849014
Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With DHS Versus PFN
A study testing Dynamic Hip Screw and Proximal Femoral Nail in people with Hip Fractures, run by Kushtrim Grezda at 1 site in Kosovo.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Dynamic Hip Screw and Proximal Femoral Nail
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Jan 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With Dynamic Hip Screw Versus Proximal Femoral Nail
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
- Being tested
- Dynamic Hip Screw, Proximal Femoral Nail
- Keywords
- Hip fractures, Inflammatory response, Interleukin-6, Comparative study
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Hip ScrewProcedure or surgery
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 NailProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Hip Screw | Active comparator | 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. Receives: Procedure: Dynamic Hip Screw |
| Proximal Femoral Nail | Active comparator | 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. Receives: Procedure: Proximal Femoral Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour before and 24 hours after operation
Secondary outcomes (8)
The difference of the level of CRP in operated patients.
The analysis will be performed immediately after the blood sample is collected.
Measured: 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 difference of the level of D-dimer
The analysis will be performed immediately after the blood sample is collected.
Measured: 1 hour before and 24 hours after operation
The difference of the level of ESR
The analysis will be performed immediately after the blood sample is collected.
Measured: 1 hour before and 24 hours after operation
The difference of the length of operation
The stopwatch will be turned on from the incision until the end of the skin suture
Measured: Intra-operatively
The difference of the level of length of incision
The measure will be made with centimeters (cm)
Measured: After the wound closure
Blood loss
HB-balance method will be used
Measured: Levels of HB before and after surgery. Also the total volume of blood transfusion.
Complications after surgery
All complications that might occur after surgery will be registered
Measured: Within 1 month after surgery
Mortality rate
The mortality of patients that might happen after surgery
Measured: Within 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Jan 2019
- Primary completion1 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kushtrim Grezda
- Sponsor type
- University, hospital or other
- Collaborators
- University Clinical Centre of Kosova
- Responsible party
- Sponsor-investigator, Kushtrim Grezda, University Clinical Centre of Kosova
- Investigators
- Kushtrim Grezda, MD, Principal investigator, University Clinical Centre of Kosova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849014
- Sponsor's protocol ID
- KGrezda
- Status last verified
- Apr 2021
- First submitted
- 17 Jan 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With Dynamic Hip Screw Versus Proximal Femoral Nail
- ClinicalTrials.gov ID
- NCT03849014
- Acronym / sponsor ID
- KGrezda
- Conditions
- Hip Fractures
- Keywords
- Hip fractures, Inflammatory response, Interleukin-6, Comparative study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kushtrim GrezdaUniversity, hospital or other
- Collaborators
- University Clinical Centre of Kosova
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Hip Screw | Active comparator | Procedure: Dynamic Hip ScrewDynamic 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. |
| Proximal Femoral Nail | Active comparator | Procedure: Proximal Femoral NailThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Polytrauma patients
- Open fractures
- Existing local or systemic infection
- Pre-existing coagulatory disorder
- Existing malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Hip ScrewDynamic 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. | Procedure or surgery | Dynamic Hip Screw |
| Proximal Femoral NailProximal 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. | Procedure or surgery | Proximal Femoral Nail |
Primary outcome
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.
8 secondary outcomes
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 difference of the level of D-dimer
Time frame: 1 hour before and 24 hours after operation
The difference of the level of ESR
Time frame: 1 hour before and 24 hours after operation
The difference of the length of operation
Time frame: Intra-operatively
The difference of the level of length of incision
Time frame: After the wound closure
Blood loss
Time frame: Levels of HB before and after surgery. Also the total volume of blood transfusion.
Complications after surgery
Time frame: Within 1 month after surgery
Mortality rate
Time frame: Within 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kushtrim Grezda, MD principal investigator
University Clinical Centre of Kosova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Hip Screw and Proximal Femoral Nail in people with Hip Fractures, run by Kushtrim Grezda at 1 site in Kosovo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kosovo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of the level of IL-6 in operated patients. (time frame: 1 hour before and 24 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.