NCT05295602

Brief Summary

The primary aim of this study is to find a possible correlation between tibial tuberosity rotation and coronal leg alignment. If correlation exists, a more individual tibial component rotation might be proposed during a total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 3, 2025

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 15, 2022

Last Update Submit

February 26, 2025

Conditions

Knee Osteoarthritis

Keywords

knee alignmentknee arthroplastytibial component rotation

Outcome Measures

Primary Outcomes (1)

  • Correlation between coronal alignment and tibial tuberosity rotation

    A hip-knee-ankle angle and a tibial rotation angle (angle between the transposed epicondylar line) will be calculated from the CT scan of the leg. A correlation between both angles will be analysed using the Spearmans's coefficient.

    Before surgery

Secondary Outcomes (2)

  • Correlation between femoral anteversion and tibial tuberosity position

    Before surgery

  • Difference in tibial tuberosity position according to the osteoarthritis grade

    Before surgery

Study Arms (1)

Group

A CT scan of both legs will be made in patient scheduled for a primary knee arthroplasty. No other additional intervention will be made apart from those already routinely used for the operation.

Radiation: CT scan

Interventions

CT scanRADIATION

CT of lower leg

Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients waiting for the knee arthroplasty will be asked to participate. Patients with pre-existing deformities will not be enrolled. Additionally, women in reproductive age will also not be enrolled to avoid unnecessary radiation risks.

You may qualify if:

  • patients requiring knee arthroplasty

You may not qualify if:

  • women in reproductive age, patients with leg deformities and previous hip/knee surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Hospital Valdoltra

Ankaran, 6820, Slovenia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Andrej Strahovnik

    Valdoltra Orthopaedic Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

March 25, 2022

Study Start

December 1, 2021

Primary Completion

December 15, 2023

Study Completion

January 1, 2024

Last Updated

March 3, 2025

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)