NCT05577780

Brief Summary

The therapeutic choice for femoral neck fracture is conventionally made between conservative treatment and total hip arthroplasty. This choice for patients aged between 45 and 64 years old remains a controversial subject. The aim of our work was to describe the current situation in the management of femoral neck fractures in these patients and to evaluate the results of the two options

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
unknown

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

Study Start

First participant enrolled

January 10, 2015

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

7.9 years

First QC Date

September 27, 2022

Last Update Submit

October 10, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • The Parker Mobility Score

    The Parker Mobility Score answers three questions, each valued 0-3 points. Based on the sum of the mobility assessment in three different situations (able to get about the house, able to get out of the house and able to go shopping), the total score ranges from 0-9. For each of the three situations the mobility has to be scored on: no difficulty (3 points), with an aid (2 points), with help from another person (1 point) or not at all (0 points). The highest overall score of 9 indicates the best possible mobility

    Baseline, Month 3

  • The Parker Mobility Score

    The Parker Mobility Score answers three questions, each valued 0-3 points. Based on the sum of the mobility assessment in three different situations (able to get about the house, able to get out of the house and able to go shopping), the total score ranges from 0-9. For each of the three situations the mobility has to be scored on: no difficulty (3 points), with an aid (2 points), with help from another person (1 point) or not at all (0 points). The highest overall score of 9 indicates the best possible mobility

    Baseline, Month 6

  • GARDEN classification

    Garden described particular femoral neck and acetabular trabeculae patterns which can assist in recognizing differences within this classification system Garden stage I: undisplaced incomplete, including valgus impacted fractures medial group of femoral neck trabeculae may demonstrate a greenstick fracture Garden stage II: undisplaced complete no disturbance of the medial trabeculae Garden stage III: complete fracture, incompletely displaced femoral head tilts into a varus position causing its medial trabeculae to be out of line with the pelvic trabeculae Garden stage IV: complete fracture, completely displaced femoral head aligned normally in the acetabulum and its medial trabeculae are in line with the pelvic trabeculae In general, stage I and II are stable fractures and can be treated with internal fixation (head-preservation) and stage III and IV are unstable fractures and hence treated with arthroplasty (either hemi- or total arthroplasty)

    Baseline

  • Postel Merle d'Aubigné score(PMA)

    the rating of Postel Merle D'Aubigné studies the pain, mobility and the walk and gives them a value from 0 to 6, allowing a global assessment of hip's function with a total of 18 marks for a normal hip. The PMA score is excellent if the score is 18, very good if the score is 17, good if the score is between 15 and 16, average if the score is between 13 and 14, poor if the score is between 9 and 12 and bad if the score is less than 9.

    Baseline, Month 3

  • Postel Merle d'Aubigné score(PMA)

    the rating of Postel Merle D'Aubigné studies the pain, mobility and the walk and gives them a value from 0 to 6, allowing a global assessment of hip's function with a total of 18 marks for a normal hip. The PMA score is excellent if the score is 18, very good if the score is 17, good if the score is between 15 and 16, average if the score is between 13 and 14, poor if the score is between 9 and 12 and bad if the score is less than 9.

    Baseline, Month 6

Study Arms (2)

internal fixation

Procedure: internal fixation

arthroplasty

Procedure: internal fixation

Interventions

Patients with femoral neck fractures are treated with pinning or hip arthroplasty, depending on the age of the patient and the presence and degree of displacement

Also known as: arthroplasty
arthroplastyinternal fixation

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Femoral neck fracture between 45 and 64 years

You may qualify if:

  • Femoral neck fracture between 45 and 64 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Fracture Fixation, InternalArthroplasty

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, OperativePlastic Surgery Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, medical doctor, assistant professor

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 13, 2022

Study Start

January 10, 2015

Primary Completion

December 10, 2022

Study Completion

January 10, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10