NCT06428760

Brief Summary

The effect of preoperative subcutaneous trochanteric fat thickness and trochanteric soft tissue thickness on postoperative infection risk in patients undergoing hemiarthroplasty for femoral neck fracture

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

April 15, 2024

Last Update Submit

May 20, 2024

Conditions

Keywords

subcutaneous trochanteric fat thicknessinfectionfemoral neck fracturesoft tissue thicknessobesityhemiarthroplasty

Outcome Measures

Primary Outcomes (2)

  • Effect of trochanteric fat and soft tissue

    The aim of this study was to evaluate the effect of peritrochanteric fat thickness and hip soft tissue parameters on postoperative wound infection in patients with femoral neck fracture. Peritrochanteric fat thickness will be measured on preoperative radiographs along with sourcil to skin surface, greater trochanter tip to skin surface, and lateral greater trochanter to skin surface values. Hip soft tissue assessment will be measured with the parameters of gluteus medius/minus, gluteus maximus, muscle thickness in the anterior and medial compartments on preoperative CT sections.

    Pre-operative

  • Wound infection

    Wound infection is assessed using investigator dressings. In assessing surgical wound infection, an ASEPSIS score will be calculated for each patient to standardise for serous exudate, erythema, purulent exudate, deep tissue separation at the wound site.

    First 3 months after surgery

Secondary Outcomes (4)

  • Hospital Length of Stay (LOS)

    1 months

  • Mortality Rate

    6 months

  • Body Mass Index

    Measured once preoperatively

  • Biochemistry Scans

    1 months

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients over 65 years of age who were admitted to our hospital with a history of a femoral neck fracture and who underwent hemiarthroplasty.

You may qualify if:

  • Patients over 65 years of age
  • Femoral neck fractures
  • Female patients
  • Patients undergoing hemiarthroplasty

You may not qualify if:

  • Patients younger than 65 years
  • Male patients
  • Patients with immunosuppressive conditions
  • Intertrochanteric fractures
  • Patients with revision surgery
  • Pathological femoral neck fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

InfectionsFemoral Neck FracturesObesity

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2024

First Posted

May 24, 2024

Study Start

May 30, 2024

Primary Completion

October 31, 2024

Study Completion

April 30, 2025

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations