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

Not Applicable

Completed

• Conditions: Femoral Neck Fractures
• Interventions: Procedure: Surgical Treatment for Impacted Femoral Neck Fracture

• Registration Number: NCT04219943
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2016-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-01
• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-05
• Last Update Submitted: 2020-01-05
• Study First Posted: 2020-01-07
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conservative Treatment for Impacted Femoral Neck Fracture	Surgical Treatment for Impacted Femoral Neck Fracture	Conservative Treatment for Impacted Femoral Neck Fracture

Primary Outcome Measures

Name	Time	Method
Harris hip score	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	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	36 months	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent