- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05577780
Femoral Neck Fracture Between 45 and 64 Years : Internal Fixation Versus Arthroplasty
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Femoral neck fracture between 45 and 64 years
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
internal fixation
|
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
Other Names:
|
|
arthroplasty
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Parker Mobility Score
Time Frame: Baseline, Month 3
|
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
Time Frame: Baseline, Month 6
|
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
Time Frame: Baseline
|
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)
Time Frame: Baseline, Month 3
|
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)
Time Frame: Baseline, Month 6
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mongislim1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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