Femoral Neck FracturesNCT04719936
Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach
A study testing inferior capsulotomy and superior capsulotomy in people with Femoral Neck Fractures, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigators will compared the clinical outcomes between superior capulotomy and inferior capsulotomy in bipolar hemiarthropalsty using posterior approach. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- inferior capsulotomy and superior capsulotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,502 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 50 years old
- displaced femoral neck fractgure
Who cannot join
- less than 50 years old
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Comparison Between Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach
Investigators will compared the clinical outcomes between superior capulotomy and inferior capsulotomy in bipolar hemiarthropalsty using posterior approach.
Read the detailed description
primary clinical outcome will be dislocation within 1 year after surgery.
- Conditions
- Femoral Neck Fractures
- Being tested
- inferior capsulotomy, superior capsulotomy
- Keywords
- Femoral Neck Fractures
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior capsulotomyProcedure or surgery
inferior capsulotomy will be conducted during posterior approach.
superior capsulotomyProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| inferior capsulotomy group | Experimental | inferior capsulotomy will be conducted during posterior approach. Receives: Procedure: inferior capsulotomy |
| superior capsulotomy group | Active comparator | 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) Receives: Procedure: superior capsulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
dislocation
rate of dislocation
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 3,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ajou University School of Medicine, Nowon Eulji Medical Center, Dankook University, Konkuk University Medical Center, Gyeongsang National University Hospital, Semyeong Christianity Hospital
- Responsible party
- Principal investigator, Young-Kyun Lee, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719936
- Sponsor's protocol ID
- PAICO study
- Status last verified
- Apr 2023
- First submitted
- 12 Jan 2021
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach
- ClinicalTrials.gov ID
- NCT04719936
- Acronym / sponsor ID
- PAICO study
- Conditions
- Femoral Neck Fractures
- Keywords
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,502 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ajou University School of Medicine, Nowon Eulji Medical Center, Dankook University, Konkuk University Medical Center, Gyeongsang National University Hospital, Semyeong Christianity Hospital
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| inferior capsulotomy group | Experimental | Procedure: inferior capsulotomyinferior capsulotomy will be conducted during posterior approach. |
| superior capsulotomy group | Active comparator | Procedure: superior capsulotomysuperior 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- more than 50 years old
- displaced femoral neck fractgure
Key exclusion criteria (1 listed)
- less than 50 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inferior capsulotomyinferior capsulotomy will be conducted during posterior approach. | Procedure or surgery | inferior capsulotomy group |
| superior capsulotomysuperior 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 or surgery | superior capsulotomy group |
Primary outcome
dislocation
Time frame: 12 months
rate of dislocation
1 secondary outcome
mobility change
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inferior capsulotomy and superior capsulotomy in people with Femoral Neck Fractures, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dislocation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.