Varus DeformityNCT05314972
Assessment of Foot Alignment and Pressure After Correction of Varus Knee by High Tibial Osteotomy or Total Knee Replacement
An observational study of Varus Deformity, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Varus Deformity
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: total coverage of all cases admitted to Assiut University Hospitals in one year
Who may be able to join
- all varus aligned knee admitted to Assiut University Hospitals (Total Knee Arthroplasty or High Tibial Osteotomy) .
Who cannot join
- patient with prior surgery of knee or foot . -secondary osteoarthritis. -valgus knee.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Varus Deformity
What is being measured
The primary outcome is the main question the study is designed to answer.
: 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:
- prospectively analyzing the correlation between the knee joint and the foot deformity.
- post-operative improvement in the foot deformity.
- the long-term post-operative changes in foot alignment.
Measured: 6-12 months
Secondary outcomes (1)
clinical assessment of the foot by american orthopedic foot&ankle society ( AOFAS) before and after knee correction
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
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Varus DeformityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Abdelaziz Khalaf Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314972
- Sponsor's protocol ID
- foot alignment and pressure
- Status last verified
- Mar 2022
- First submitted
- 31 Dec 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 6825330Fang 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.
PubMed 19553073Jeffery 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.
PubMed 1894655Longstaff 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.
PubMed 18534396Cho 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.
PubMed 27527338Norton 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.
PubMed 25024033Hara 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.
PubMed 25155238Mullaji 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.
PubMed 21120711
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Foot Alignment and Pressure After Correction of Varus Knee by High Tibial Osteotomy or Total Knee Replacement
- ClinicalTrials.gov ID
- NCT05314972
- Acronym / sponsor ID
- foot alignment and pressure
- Conditions
- Varus Deformity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- total coverage of all cases admitted to Assiut University Hospitals in one year
Key inclusion criteria (1 listed)
- all varus aligned knee admitted to Assiut University Hospitals (Total Knee Arthroplasty or High Tibial Osteotomy) .
Key exclusion criteria (1 listed)
- patient with prior surgery of knee or foot . -secondary osteoarthritis. -valgus knee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
: 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: 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.
1 secondary outcome
clinical assessment of the foot by american orthopedic foot&ankle society ( AOFAS) before and after knee correction
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Background: PubMed 6825330Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty. Correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983 Mar;(173):178-83.
- Background: PubMed 19553073Fang 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.
- Background: PubMed 1894655Jeffery 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.
- Background: PubMed 18534396Longstaff 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.
- Background: PubMed 27527338Cho 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.
- Background: PubMed 25024033Norton 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.
- Background: PubMed 25155238Hara 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.
- Background: PubMed 21120711Mullaji 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Varus Deformity, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdelrhman abdelaziz khalaf (01096836732, Zizoo23295@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314972, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.