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

Femoral Neck Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219943
• Other study ID #: KY20100103-02
• Status: Completed
• Phase: N/A
• Start date: January 1, 2010
• Est. completion date: October 31, 2019

Study information

• Verified date: January 2020
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 97 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Surgical Treatment for Impacted Femoral Neck Fracture
Surgical Treatment for Impacted Femoral Neck Fracture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent	36 months
Primary	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).	36 months
Primary	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.	36 months