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NCT04719936 Clinical Trial

Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach

Femoral Neck Fractures Clinical Trial

Official title:
Comparison Between Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04719936
Other study ID # PAICO study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2022

Study information
Verified date April 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 3502
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - more than 50 years old - displaced femoral neck fractgure Exclusion Criteria: - less than 50 years old

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• inferior capsulotomy
inferior capsulotomy will be conducted during posterior approach.
• 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)

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (7)
Lead Sponsor Collaborator
Seoul National University Hospital Ajou University School of Medicine, Dankook University, Gyeongsang National University Hospital, Konkuk University Medical Center, Nowon Eulji Medical Center, Semyeong Christianity Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary dislocation rate of dislocation 12 months
Secondary 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 12 months
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