Skip to main content
Clinical Trials/NCT04219943
NCT04219943
Completed
Not Applicable

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

Nanjing First Hospital, Nanjing Medical University0 sites154 target enrollmentJanuary 1, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femoral Neck Fractures
Sponsor
Nanjing First Hospital, Nanjing Medical University
Enrollment
154
Primary Endpoint
Harris hip score
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2010
End Date
October 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

Harris hip score

Time Frame: 36 months

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

Time Frame: 36 months

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.

visual analog scale

Time Frame: 36 months

visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent

Similar Trials