Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach

NCT ID: NCT04719936

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Femoral Neck Fractures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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inferior capsulotomy group

inferior capsulotomy will be conducted during posterior approach.

Group Type EXPERIMENTAL

inferior capsulotomy

Intervention Type PROCEDURE

inferior capsulotomy will be conducted during posterior approach.

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)

Group Type ACTIVE_COMPARATOR

superior capsulotomy

Intervention Type PROCEDURE

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)

Interventions

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inferior capsulotomy

inferior capsulotomy will be conducted during posterior approach.

Intervention Type PROCEDURE

superior 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)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* more than 50 years old
* displaced femoral neck fractgure

Exclusion Criteria

* less than 50 years old
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role collaborator

Nowon Eulji Medical Center

UNKNOWN

Sponsor Role collaborator

Dankook University

OTHER

Sponsor Role collaborator

Konkuk University Medical Center

OTHER

Sponsor Role collaborator

Gyeongsang National University Hospital

OTHER

Sponsor Role collaborator

Semyeong Christianity Hospital

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young-Kyun Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PAICO study

Identifier Type: -

Identifier Source: org_study_id

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