Femoral External Rotation Measured on CT and MRI | NCT05327413

Studies
Femoral External Rotation Measured on CT and MRI

NCT05327413

Sponsor

The Affiliated Hospital of Qingdao University

Status

Unknown status

Last Update Posted

Apr 21, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Knee Osteoarthritis

Interventions

CT and MRI

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Apr 7, 2022

First Submission Date that Met QC Criteria

Apr 7, 2022

First Posted Date

Apr 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2022

Last Update Posted Date

Apr 21, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

xiangshuai, Principal Investigator, The Affiliated Hospital of Qingdao UniversityPrincipal Investigator

Lead Sponsor

The Affiliated Hospital of Qingdao UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to compare the femoral external rotation measured on CT and MRI to that measured intraoperatively to clarify the influence of residual cartilage on posterior condyle on the preoperative planning of total knee arthroplasty.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Other: CT and MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT and MRI	Other	CT and MRI were conducted to measure the femoral external rotation	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Femoral external rotation on CT	the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on CT	Preoperative
Femoral external rotation on MRI	the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on MRI	Preoperative
Intraoperative femoral external rotation	the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) measured intraoperatively	Intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

50-85 years old
patients with osteoarthritis (Kellgren-Lawrence Grade III or IV) underwent total knee arthroplasty.

Exclusion Criteria:

patients cannot endure TKA due to severe heart failure, arrhythmia, myocardial infarction, infection or other reason.
patients who cannot undergo MRI.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients underwent TKA due to knee arthroplasty (Kellgren-Lawrence Grade III or IV)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jie Zhu	Contact	0532-82911869		15169093669@163.com

Overall Officials

Name	Affiliation	Role
Shuai Xiang	The Affiliated Hospital of Qingdao University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The affiliated hospital of Qingdao University	Recruiting	Qingdao	Shandong		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided