Back to resultsConservative 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
About this trial
This is an interventional treatment trial for Femoral Neck Fractures
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.
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
NCT ID
NCT04219943
First Posted
January 5, 2020
Last Updated
January 5, 2020
Sponsor
Nanjing First Hospital, Nanjing Medical University
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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