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

Sponsor
Mongi Slim Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05577780
Collaborator
(none)
60
96

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: internal fixation

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Femoral Neck Fracture Between 45 and 64 Years : Internal Fixation Versus Arthroplasty
Actual Study Start Date :
Jan 10, 2015
Anticipated Primary Completion Date :
Dec 10, 2022
Anticipated Study Completion Date :
Jan 10, 2023

Arms and Interventions

Arm Intervention/Treatment
internal fixation

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
Other Names:
  • arthroplasty
  • arthroplasty

    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
    Other Names:
  • arthroplasty
  • Outcome Measures

    Primary Outcome Measures

    1. The Parker Mobility Score [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

    2. The Parker Mobility Score [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

    3. GARDEN classification [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)

    4. Postel Merle d'Aubigné score(PMA) [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.

    5. Postel Merle d'Aubigné score(PMA) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Femoral neck fracture between 45 and 64 years

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mongi Slim Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mohamed hedi ezzine, Principal Investigator, medical doctor, assistant professor, Mongi Slim Hospital
    ClinicalTrials.gov Identifier:
    NCT05577780
    Other Study ID Numbers:
    • mongislim1
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Oct 13, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2022