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CompletedNCT04219943Updated Jan 7, 2020

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

An interventional study of Surgical Treatment for Impacted Femoral Neck Fracture in Femoral Neck Fractures, sponsored by Nanjing First Hospital, Nanjing Medical University. Completed. Open to participants aged 75 Years to 97 Years. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 years after the study started (first participant enrolled Jan 2010, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Not applicable
Ages
75 Years to 97 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Femoral Neck Fractures
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In context

Femoral Neck Fractures

210 studies on the registry are indexed under Femoral Neck Fractures; 42 are open to participants now.

This study's enrollment of 154 is above the median of 100 across 146 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 220 studies on the registry; 107 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
75 Years to 97 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    Conservative Treatment for Impacted Femoral Neck Fracture

    Conservative Treatment for Impacted Femoral Neck Fracture

    Procedure: Surgical Treatment for Impacted Femoral Neck Fracture

Interventions

  • ProcedureSurgical Treatment for Impacted Femoral Neck Fracture

    Surgical Treatment for Impacted Femoral Neck Fracture

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What researchers measure

Primary outcomes

  1. visual analog scale

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

    Time frame: 36 months

  2. 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).

    Time frame: 36 months

  3. 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.

    Time frame: 36 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 32413174 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2010 to primary completion in Oct 2016, 81 months.

Of 68 non-industry interventional studies with no phase under Femoral Neck Fractures, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 62. This study's 81 months is above that.

Counting every sponsor, half of 74 studies reached it within 47 months; a quarter within 25 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2020
First posted
Jan 7, 2020
StartActual
Jan 1, 2010
Primary completionActual
Oct 31, 2016
CompletionActual
Oct 31, 2019
Last update
Jan 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04219943
Responsible party
Sponsor
First posted
Jan 7, 2020
Start date
Jan 1, 2010
Primary completion
Oct 31, 2016
Completion
Oct 31, 2019
Last update
Jan 7, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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