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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04219943
Enrollment
154
Registered
2020-01-07
Start date
2010-01-01
Completion date
2019-10-31
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Fractures

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.

Interventions

PROCEDURESurgical Treatment for Impacted Femoral Neck Fracture

Surgical Treatment for Impacted Femoral Neck Fracture

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to 97 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
visual analog scale36 monthsvisual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent
Harris hip score36 monthsThe 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 scores36 monthsTo 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026