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Conservative Versus Surgical Treatment of Impacted Femoral Neck Fracture in Patient 75 Years Old and Older

Primary Purpose

Femoral Neck Fractures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgical Treatment for Impacted Femoral Neck Fracture
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures

Eligibility Criteria

75 Years - 97 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients >75 years old who were diagnosed with impacted femoral neck fracture with confirmation of mutual embedding and close combination of the fracture ends by CT or MRI scanning(including Garden 1 and 2 and varus impacted FNF) were eligible for the inclusion.

Exclusion Criteria:

Patients <75 years old, pathological fracture, nonimpacted or displaced fracture, unable to walk previously, avascular necrosis of femoral head, previous symptomatic hip pathology (such as arthritis), infection, a history of fracture in the studied hip, deformity of lower limb.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Conservative Treatment for Impacted Femoral Neck Fracture

    Arm Description

    Conservative Treatment for Impacted Femoral Neck Fracture

    Outcomes

    Primary Outcome Measures

    visual analog scale
    visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent
    Harris hip score
    The score has a maximum of 100 points (no disability), covering pain (0-44 points), function (0-47 points), and range of motion and absence of deformity (0-9 points).
    Eq-5d index scores
    To rate current state of health on five dimensions (mobility, personal hygiene, usual activities, pain/discomfort, and anxiety/depression) with three possible responses for each item (no problem, some problem, unable/large problem). Integral formula: V=1-Constant-Mobility-Self-care-Usual activity-Pain/discomfort-Anxiety/depression-N3.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2020
    Last Updated
    January 5, 2020
    Sponsor
    Nanjing First Hospital, Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04219943
    Brief Title
    Conservative Versus Surgical Treatment of Impacted Femoral Neck Fracture in Patient 75 Years Old and Older
    Official Title
    Conservative Versus Surgical Treatment of Impacted Femoral Neck Fracture in Patient 75 Years Old and Older
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    October 31, 2016 (Actual)
    Study Completion Date
    October 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanjing First Hospital, Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the safety and effectiveness of conservative treatment in treatment of patients over 75 years with impacted femoral neck fracture.
    Detailed Description
    The study is to compare clinical outcomes between conservative treatment, internal fixation, and hemiarthroplasty in patients over 75 years with impacted femoral neck fracture. All the 3 groups were evaluated by hip pain(visual analogue scale,VAS), hip function(Harris hip score,HHS), health related quality of life(European Quality of Life-5 Dimensions index scores, Eq-5d). All thses parameters were assessed at admission and 1-, 3-, 6- 12-, 24- and 36 months after intervention. Operation duration and blood loss were recorded. Mortality, union rate, complications and re-operation were also monitored throughout the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femoral Neck Fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conservative Treatment for Impacted Femoral Neck Fracture
    Arm Type
    Experimental
    Arm Description
    Conservative Treatment for Impacted Femoral Neck Fracture
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical Treatment for Impacted Femoral Neck Fracture
    Intervention Description
    Surgical Treatment for Impacted Femoral Neck Fracture
    Primary Outcome Measure Information:
    Title
    visual analog scale
    Description
    visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent
    Time Frame
    36 months
    Title
    Harris hip score
    Description
    The score has a maximum of 100 points (no disability), covering pain (0-44 points), function (0-47 points), and range of motion and absence of deformity (0-9 points).
    Time Frame
    36 months
    Title
    Eq-5d index scores
    Description
    To rate current state of health on five dimensions (mobility, personal hygiene, usual activities, pain/discomfort, and anxiety/depression) with three possible responses for each item (no problem, some problem, unable/large problem). Integral formula: V=1-Constant-Mobility-Self-care-Usual activity-Pain/discomfort-Anxiety/depression-N3.
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    75 Years
    Maximum Age & Unit of Time
    97 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients >75 years old who were diagnosed with impacted femoral neck fracture with confirmation of mutual embedding and close combination of the fracture ends by CT or MRI scanning(including Garden 1 and 2 and varus impacted FNF) were eligible for the inclusion. Exclusion Criteria: Patients <75 years old, pathological fracture, nonimpacted or displaced fracture, unable to walk previously, avascular necrosis of femoral head, previous symptomatic hip pathology (such as arthritis), infection, a history of fracture in the studied hip, deformity of lower limb.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32413174
    Citation
    Wei P, Xu Y, Gu Y, Geng D, Yao Q, Wang L. Conservative vs Surgical Treatment of Impacted Femoral Neck Fracture in Patients 75 Years and Older. J Am Geriatr Soc. 2020 Oct;68(10):2214-2221. doi: 10.1111/jgs.16535. Epub 2020 May 15.
    Results Reference
    derived

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    Conservative Versus Surgical Treatment of Impacted Femoral Neck Fracture in Patient 75 Years Old and Older

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