Femoral Neck Fracture Between 45 and 64 Years : Internal Fixation Versus Arthroplasty

Femoral Neck Fractures Clinical Trial

Official title:

Femoral Neck Fracture Between 45 and 64 Years : Internal Fixation Versus Arthroplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05577780
• Other study ID #: mongislim1
• Status: Enrolling by invitation
• Start date: January 10, 2015
• Est. completion date: January 10, 2023

Study information

• Verified date: October 2022
• Source: Mongi Slim Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Our study was retrospective descriptive including patients aged between 45 and 64 years operated between January 2015 and December 2022 for femoral neck fracture. The patients will be divided into two groups: The internal fixation group and the arthroplasty group . Epidemiological, clinical and radiological data as well as therapeutic results and postoperative complications will be analysed.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: January 10, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

Inclusion Criteria:

• Femoral neck fracture between 45 and 64 years

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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