- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05314972
Assessment of Foot Alignment and Pressure After Correction of Varus Knee by High Tibial Osteotomy or Total Knee Replacement
Study Overview
Status
Conditions
Detailed Description
The mechanical alignment of the lower extremity is an important consideration in the long-term outcome following total knee arthroplasty (TKA) or high tibial osteotomy (HTO) . Alignment between the hip and the ankle through the knee joint has been used in determining coronal alignment, based on the assumption that weight-bearing forces pass through the centre of the knee joint during neutral mechanical. However, the weight-bearing vector can be affected by hindfoot and midfoot alignment because load is transmitted not from the ankle joint, but from the ground reaction point. Thus hindfoot alignment after knee correction may critically affect the longevity of the prosthesis
Most patients with some degree of knee joint deformity, which in turn may be associated with a deformity of the foot. In fact, an association between varus alignment of the knee joint and valgus alignment of the foot in osteoarthritis patients has been reported. Because the subtalar joint compensates for the knee joint deformity , correction of the deformity after TKA or HTO can affect foot alignment. Improvements in midfoot and hindfoot alignment have been noted in patients with osteoarthritis after correction of deformity. However, foot valgus may also persist, with little improvement after knee correction.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: abdelrhman abdelaziz khalaf
- Phone Number: 01096836732
- Email: Zizoo23295@gmail.com
Study Contact Backup
- Name: Wael yossef El-adly
- Phone Number: 01224265850
- Email: eladlyw@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all varus aligned knee admitted to Assiut University Hospitals (Total Knee Arthroplasty or High Tibial Osteotomy) .
Exclusion Criteria:
- patient with prior surgery of knee or foot . -secondary osteoarthritis. -valgus knee.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
: Radiological changes in hindfoot and midfoot alignment after correction of varus knee by High tibial osteotomy (HTO) or total knee arthroplasty(TKA)
Time Frame: 6-12 months
|
This study evaluated the change in foot alignment after TKA or HTO by:
|
6-12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical assessment of the foot by american orthopedic foot&ankle society ( AOFAS) before and after knee correction
Time Frame: 6-12 months
|
AOFAS covers four different regions of the foot: The ankle-hindfoot, midfoot, metatarsophalangeal (MTP)-interphalangeal (IP) for the hallux, and MTP-IP for the lesser toes.These four anatomic regions have their own version of the AOFAS survey.
Each c is designed to be used independent of the others.
However, each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points).
These are all scored together for a total of 100 points
|
6-12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- foot alignment and pressure
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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