NCT03628664

Brief Summary

Total knee arthroplasty is one of the most common management methods of knee osteoarthritis. Patellar complications are one of the important causes of revision total knee arthroplasty. Proper placement of the components in the best rotational and axial alignment would achieve better patellar tracking and the best functional outcomes. Preoperative CT scan can add information regarding the coronal and rotational alignment of the prosthesis components.

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
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable knee-osteoarthritis

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

First Submitted

Initial submission to the registry

July 25, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

July 25, 2018

Last Update Submit

August 10, 2018

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Knee Society score (KSS)

    one year

  • Western Ontario and McMaster university osteoarthritis index (WOMAC) score

    One year

Secondary Outcomes (4)

  • Patient satisfaction: Knee Society score(KSS) subscale

    one year

  • Patellofemoral functional score

    one year

  • Revision rate

    one year

  • Knee range of motion

    one year

Study Arms (2)

CT planned total knee arthroplasty

ACTIVE COMPARATOR

Surgeon will follow the CT plan

Radiation: CT scan

Non CT planned total knee arthroplasty

NO INTERVENTION

Surgeon will not follow the CT plan

Interventions

CT scanRADIATION

Assessment of the actual posterior condylar angle using the CT scan

CT planned total knee arthroplasty

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced knee osteoarthritis in which total knee arthroplasty is indicated

You may not qualify if:

  • Revision total knee arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Univrsity

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ahmed Saeed Younis, Dr.

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • Radwan Gamal Abdel Hamid, Dr.

    Ain Shams University

    STUDY DIRECTOR

  • Mohamed Awad, Dr.

    Ain Shams University

    STUDY DIRECTOR

  • Wael Samir Osman, professor

    Ain Shams University

    STUDY CHAIR

  • Tarek Mohammed Samy, Professor

    Ain Shams University

    STUDY CHAIR

Central Study Contacts

Ahmed Saeed Younis, Dr.

CONTACT

201012370677ahmed.s.younis@med.asu.edu.eg

Radwan Gamal Abdel Hamid, Dr.

CONTACT

201272221906dr_radwan05@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical investigator

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 14, 2018

Study Start

September 1, 2018

Primary Completion

July 1, 2019

Study Completion

December 1, 2020

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

EG(1)