Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach

Study Overview
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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.

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

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Procedure: inferior capsulotomy
* Procedure: superior capsulotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more than 50 years old displaced femoral neck fractgure Exclusion Criteria: less than 50 years old

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inferior capsulotomy group<br>inferior capsulotomy will be conducted during posterior approach. | Procedure: inferior capsulotomy<br>* inferior capsulotomy will be conducted during posterior approach.<br>|
| Active Comparator: superior capsulotomy group<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dislocation | rate of dislocation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral Neck Fractures