Diffrence in Thromboprofilaksis in Elderly Ostoepenic Hip Fractures According to Mobility Status by Genetic Analysis

NCT ID: NCT06959017

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-01

Brief Summary

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Hip fracture is a common and severe disease in elderly patients. The question of the study is whether elderly patients with severe osteopenia have significantly lower levels of the collagen-binding protein Hsp47 than relatively mobile patients due to advanced immobility before the fracture, and whether they participants have a similar risk of VTE to the normal population despite having had a hip fracture and surgery.

Detailed Description

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In this study, the investigators aimed to prospectively measure the Hsp 47 gene expression levels in patients scheduled for surgery due to intertrochanteric femur fracture and healthy volunteers in the same age group and compare the results with the literature.

Also the complications prior or after surgery will be compared.

Conditions

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Hip Fracture of Intertrochanteric Type Thromboembolic Event Osteopenia Thrombosis Embolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

All patients undergo genetic expression analysis of HSP 47 (SERPİNH1, ROCK1) and the also classified by their mobility score before fracture. There is also a control group consist of age appropied healty adults
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sedentary

This group is consist of the patients with pre-fracture mobility score 3-4-5

Group Type ACTIVE_COMPARATOR

Gene Expression Analysis

Intervention Type GENETIC

Each subject analysed for SERPİNH1 and ROCK1 gene exppression

Active

This group is consist of the patients with pre-fracture mobility score 1-2

Group Type EXPERIMENTAL

Gene Expression Analysis

Intervention Type GENETIC

Each subject analysed for SERPİNH1 and ROCK1 gene exppression

Control

This group is consist of the volunteered healty people which \>65 years of age

Group Type EXPERIMENTAL

Gene Expression Analysis

Intervention Type GENETIC

Each subject analysed for SERPİNH1 and ROCK1 gene exppression

Interventions

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Gene Expression Analysis

Each subject analysed for SERPİNH1 and ROCK1 gene exppression

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* \>65 years of age
* Interthrocanteric femur fracture AO Type 31A1, 31A2, 31A3
* Patients treated proksimal femoral nail
* Minor trauma
* Fracture mobility score 1,2,3,4,5
* Inial thrombocytes count 150.000-450.000 /µL

Exclusion Criteria

* Body mass index \>40
* Fracture mobility score 6 (unknown type)
* stage 4 chronic kidney disease
* Patients with rheumatological diseases
* Patients at serious risk of VTE(Venous thromboembolism) (according to the International Society on Thrombosis and Hemostasis, categorization of venous thromboembolism) :
* Active Hematologic Cancer
* Antiphospholipid syndrome
* History of recurrent thrombosis (DVT)
* Paroxysmal nocturnal hemoglobinuria
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sağlık Bilimleri University

UNKNOWN

Sponsor Role collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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İsmail Demirkale

Prof. Dr. İsmail Demirkale

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İsmail Demirkale, Prof Dr

Role: STUDY_CHAIR

Saglik Bilimleri Universty

Locations

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Prof Dr emil Tascıoglu City Hospital

Istanbul, Şişli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Thienel M, Muller-Reif JB, Zhang Z, Ehreiser V, Huth J, Shchurovska K, Kilani B, Schweizer L, Geyer PE, Zwiebel M, Novotny J, Lusebrink E, Little G, Orban M, Nicolai L, El Nemr S, Titova A, Spannagl M, Kindberg J, Evans AL, Mach O, Vogel M, Tiedt S, Ormanns S, Kessler B, Dueck A, Friebe A, Jorgensen PG, Majzoub-Altweck M, Blutke A, Polzin A, Stark K, Kaab S, Maier D, Gibbins JM, Limper U, Frobert O, Mann M, Massberg S, Petzold T. Immobility-associated thromboprotection is conserved across mammalian species from bear to human. Science. 2023 Apr 14;380(6641):178-187. doi: 10.1126/science.abo5044. Epub 2023 Apr 13.

Reference Type BACKGROUND
PMID: 37053338 (View on PubMed)

Other Identifiers

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01.04.2024-65

Identifier Type: -

Identifier Source: org_study_id

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