Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04719936
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Young-Kyun Lee, Seoul National University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Investigators will compared the clinical outcomes between superior capulotomy and inferior capsulotomy in bipolar hemiarthropalsty using posterior approach.

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Procedure: inferior capsulotomy Procedure: superior capsulotomy Not Applicable

Detailed Description:
primary clinical outcome will be dislocation within 1 year after surgery.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: inferior capsulotomy group
inferior capsulotomy will be conducted during posterior approach.
 Procedure: inferior capsulotomy
inferior capsulotomy will be conducted during posterior approach.
Active Comparator: superior capsulotomy group
superior capsulotomy will be conducted during posterior approach.
 Procedure: superior capsulotomy
superior capsulotomy will be conducted during posterior approach.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. dislocation [ Time Frame: 3 months ]
    rate of dislocation

  2. dislocation [ Time Frame: 6 months ]
    rate of dislocation

  3. dislocation [ Time Frame: 9 months ]
    rate of dislocation

  4. dislocation [ Time Frame: 12 months ]
    rate of dislocation


Secondary Outcome Measures :
  1. mobility change [ Time Frame: 3 months ]
    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

  2. mobility change [ Time Frame: 6 months ]
    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

  3. mobility change [ Time Frame: 9 months ]
    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

  4. mobility change [ Time Frame: 12 months ]
    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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • more than 50 years old
  • displaced femoral neck fractgure

Exclusion Criteria:

  • less than 50 years old
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719936


Contacts
Layout table for location contacts
Contact: Young-Kyun Lee 82-31-787-7204 ykleemd@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 13620
Contact: Young-Kyun Lee    82-31-787-7204    ykleemd@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Young-Kyun Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04719936    
Other Study ID Numbers: PAICO study
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Young-Kyun Lee, Seoul National University Hospital:
Femoral Neck Fractures
Additional relevant MeSH terms:
Layout table for MeSH terms
Femoral Neck Fractures
Fractures, Bone
Wounds and Injuries
Hip Fractures
 Femoral Fractures
Hip Injuries
Leg Injuries