NCT05314972

Brief Summary

This study evaluated the change in foot alignment after TKA or HTO by prospectively analyzing the correlation between the knee joint and the foot deformity, the post-operative improvement in the foot deformity, and the long-term post-operative changes in foot alignment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

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

December 31, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

December 31, 2021

Last Update Submit

March 27, 2022

Conditions

Varus Deformity

Outcome Measures

Primary Outcomes (1)

  • : Radiological changes in hindfoot and midfoot alignment after correction of varus knee by High tibial osteotomy (HTO) or total knee arthroplasty(TKA)

    This study evaluated the change in foot alignment after TKA or HTO by: 1. prospectively analyzing the correlation between the knee joint and the foot deformity. 2. post-operative improvement in the foot deformity. 3. the long-term post-operative changes in foot alignment.

    6-12 months

Secondary Outcomes (1)

  • clinical assessment of the foot by american orthopedic foot&ankle society ( AOFAS) before and after knee correction

    6-12 months

Eligibility Criteria

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

total coverage of all cases admitted to Assiut University Hospitals in one year

You may qualify if:

  • all varus aligned knee admitted to Assiut University Hospitals (Total Knee Arthroplasty or High Tibial Osteotomy) .

You may not qualify if:

  • patient with prior surgery of knee or foot . -secondary osteoarthritis. -valgus knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty. Correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983 Mar;(173):178-83.

    PMID: 6825330BACKGROUND

  • Fang DM, Ritter MA, Davis KE. Coronal alignment in total knee arthroplasty: just how important is it? J Arthroplasty. 2009 Sep;24(6 Suppl):39-43. doi: 10.1016/j.arth.2009.04.034. Epub 2009 Jun 24.

    PMID: 19553073BACKGROUND

  • Jeffery RS, Morris RW, Denham RA. Coronal alignment after total knee replacement. J Bone Joint Surg Br. 1991 Sep;73(5):709-14. doi: 10.1302/0301-620X.73B5.1894655.

    PMID: 1894655BACKGROUND

  • Longstaff LM, Sloan K, Stamp N, Scaddan M, Beaver R. Good alignment after total knee arthroplasty leads to faster rehabilitation and better function. J Arthroplasty. 2009 Jun;24(4):570-8. doi: 10.1016/j.arth.2008.03.002. Epub 2008 May 19.

    PMID: 18534396BACKGROUND

  • Cho WS, Cho HS, Byun SE. Changes in hindfoot alignment after total knee arthroplasty in knee osteoarthritic patients with varus deformity. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3596-3604. doi: 10.1007/s00167-016-4278-8. Epub 2016 Aug 16.

    PMID: 27527338BACKGROUND

  • Norton AA, Callaghan JJ, Amendola A, Phisitkul P, Wongsak S, Liu SS, Fruehling-Wall C. Correlation of knee and hindfoot deformities in advanced knee OA: compensatory hindfoot alignment and where it occurs. Clin Orthop Relat Res. 2015 Jan;473(1):166-74. doi: 10.1007/s11999-014-3801-9.

    PMID: 25024033BACKGROUND

  • Hara Y, Ikoma K, Arai Y, Ohashi S, Maki M, Kubo T. Alteration of hindfoot alignment after total knee arthroplasty using a novel hindfoot alignment view. J Arthroplasty. 2015 Jan;30(1):126-9. doi: 10.1016/j.arth.2014.07.026. Epub 2014 Jul 25.

    PMID: 25155238BACKGROUND

  • Mullaji A, Shetty GM. Persistent hindfoot valgus causes lateral deviation of weightbearing axis after total knee arthroplasty. Clin Orthop Relat Res. 2011 Apr;469(4):1154-60. doi: 10.1007/s11999-010-1703-z. Epub 2010 Dec 1.

    PMID: 21120711BACKGROUND

Central Study Contacts

abdelrhman abdelaziz khalaf

CONTACT

01096836732Zizoo23295@gmail.com

Wael yossef El-adly

CONTACT

01224265850eladlyw@aun.edu.eg

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

December 31, 2021

First Posted

April 7, 2022

Study Start

May 1, 2022

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

April 7, 2022

Record last verified: 2022-03