NCT04719936

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,502

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 10, 2025

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

January 12, 2021

Last Update Submit

June 5, 2025

Conditions

Femoral Neck Fractures

Keywords

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

  • dislocation

    rate of dislocation

    12 months

Secondary Outcomes (1)

  • mobility change

    12 months

Study Arms (2)

inferior capsulotomy group

EXPERIMENTAL

inferior capsulotomy will be conducted during posterior approach.

Procedure: inferior capsulotomy

superior capsulotomy group

ACTIVE COMPARATOR

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

inferior capsulotomyPROCEDURE

inferior capsulotomy will be conducted during posterior approach.

inferior capsulotomy group
superior capsulotomyPROCEDURE

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)

superior capsulotomy group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 50 years old
  • displaced femoral neck fractgure

You may not qualify if:

  • less than 50 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Inferior capsulotomy in bipolar hemiarthroplasty will be performed in 25 patients. As control group, historical group of patients who received bipolar hemiarthroplasty using superior capsulotomy from January 2010 to December 2020 will be included. A total of 5500 patients are to be included in multicenters.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 22, 2021

Study Start

December 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

June 10, 2025

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)