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Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach

Primary Purpose

Femoral Neck Fractures

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
inferior capsulotomy
superior capsulotomy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Femoral Neck Fractures

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • more than 50 years old
  • displaced femoral neck fractgure

Exclusion Criteria:

  • less than 50 years old

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

inferior capsulotomy group

superior capsulotomy group

Arm Description

inferior capsulotomy will be conducted during posterior approach.

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)

Outcomes

Primary Outcome Measures

dislocation
rate of dislocation

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2021
Last Updated
April 20, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT04719936
Brief Title
Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach
Official Title
Comparison Between Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigators will compared the clinical outcomes between superior capulotomy and inferior capsulotomy in bipolar hemiarthropalsty using posterior approach.
Detailed Description
primary clinical outcome will be dislocation within 1 year after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
Femoral Neck Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inferior capsulotomy group
Arm Type
Experimental
Arm Description
inferior capsulotomy will be conducted during posterior approach.
Arm Title
superior capsulotomy group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
inferior capsulotomy
Intervention Description
inferior capsulotomy will be conducted during posterior approach.
Intervention Type
Procedure
Intervention Name(s)
superior capsulotomy
Intervention Description
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)
Primary Outcome Measure Information:
Title
dislocation
Description
rate of dislocation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
mobility change
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: more than 50 years old displaced femoral neck fractgure Exclusion Criteria: less than 50 years old
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach

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