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CompletedNCT04719936Updated Jun 10, 2025

Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach

An interventional study of inferior capsulotomy and superior capsulotomy in Femoral Neck Fractures, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
3,502
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study summary

Investigators will compared the clinical outcomes between superior capulotomy and inferior capsulotomy in bipolar hemiarthropalsty using posterior approach.

Read the detailed description

primary clinical outcome will be dislocation within 1 year after surgery.

02

Conditions studied

  • Femoral Neck Fractures

Keywords

  • Femoral Neck Fractures
03

In context

Femoral Neck Fractures

204 studies on the registry are indexed under Femoral Neck Fractures; 41 are open to participants now.

This study's enrollment of 3,502 is above the median of 100 across 140 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

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

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • more than 50 years old
  • displaced femoral neck fractgure

Exclusion criteria

Exclusion Criteria:

  • less than 50 years old
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,502 participants (actual)

Study arms

  • Experimental
    inferior capsulotomy group

    inferior capsulotomy will be conducted during posterior approach.

    Procedure: inferior capsulotomy

  • Active comparator
    superior capsulotomy group

    superior capsulotomy was conducted during posterior approach. (These control group is consisted of patients who received bipolar hemiarthroplasty using superior capsulotomy from January 2010 to December 2020)

    Procedure: superior capsulotomy

Interventions

  • Procedureinferior capsulotomy

    inferior capsulotomy will be conducted during posterior approach.

  • Proceduresuperior capsulotomy

    superior capsulotomy was conducted during posterior approach. (These control group is consisted of patients who received bipolar hemiarthroplasty using superior capsulotomy from January 2010 to December 2020)

06

What researchers measure

Primary outcomes

  1. dislocation

    rate of dislocation

    Time frame: 12 months

Secondary outcomes

  1. mobility change

    change of mobility according to Koval classification; independent community ambulatory community ambulatory with cane community ambulatory with crutch, walker independent household ambulatory household ambulatory with cane household ambulatory with crutch, walker nonfunctional ambulatory

    Time frame: 12 months

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 13620, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04719936
Lead sponsor
Seoul National University Hospital
Collaborators
Ajou University School of Medicine, Nowon Eulji Medical Center, Dankook University, Konkuk University Medical Center, Gyeongsang National University Hospital, Semyeong Christianity Hospital
Responsible party
Young-Kyun Lee (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jan 22, 2021
Start date
Dec 1, 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2022
Last update
Jun 10, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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