NCT05327413

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

April 7, 2022

Last Update Submit

April 14, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Group 1

Other: CT and MRI

Interventions

CT and MRIOTHER

CT and MRI were conducted to measure the femoral external rotation

Group 1

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The affiliated hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Shuai Xiang

    The Affiliated Hospital of Qingdao University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Zhu

CONTACT

0532-8291186915169093669@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

April 1, 2022

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations

CN(1)