OsteoarthritisNCT02583503
Hindfoot Alignment in Total Knee Replacement
An observational study of Osteoarthritis, run by Golden Jubilee National Hospital.
Trial summary
When carrying out a knee replacement operation one of the goals is to correct any deformity of the leg (bowlegged or knock kneed). The ideal alignment is the mechanical axis, which is a line from the centre of the hip joint to the centre of the ankle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hindfoot alignment view x ray
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2015to 28 Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for a total knee replacement at the Golden Jubilee National Hospital under the care of one of the orthopaedic consultants who have agreed to provide patients for this study.
Who may be able to join
- Predominant knee osteoarthritis requiring total knee replacement
- Able to give informed consent
- Able to return for 6 week follow-up
Who cannot join
- Advanced osteoarthritis in other lower limb joint(s)
- limb length discrepancy requiring a shoe-raise
About this study
Official title: Hindfoot Alignment in TKR - Validation of a Novel Radiographic Study
When carrying out a knee replacement operation one of the goals is to correct any deformity of the leg (bowlegged or knock kneed). The ideal alignment is the mechanical axis, which is a line from the centre of the hip joint to the centre of the ankle. This line indicates how the weight of the body is transmitted to the ground via the leg. Often the planning for a knee replacement uses an Xray which shows the hip, knee and ankle (HKA Xray) so that the mechanical axis can be drawn on.
However, the weight of the body goes to the ground from the ankle through the heel. There have been some reports recently suggesting that deformities in the heel can influence the overall leg alignment after a knee replacement; this may affect how successful the surgery is, or how long the knee replacement will last. Therefore it may make sense to take the alignment of the leg including the heel in planning for a knee replacement.
Read more
The conventional practice to assess the alignment of the heel is a hindfoot alignment view (HAV) Xray. This only shows the foot. Having two separate Xrays means more radiation exposure and makes linking the two alignments very difficult. We propose a single novel Xray extending the HKA Xray to shows hip, knee, ankle and heel (HKAH Xray) enabling measurement of both alignments.
This study is to validate the hindfoot alignment seen on the novel Xray with the standard HAV. Patients undergoing a knee replacement will be enrolled. Patients will have both a HKAH and HAV Xray before surgery. The alignment of the heel measured on the HKAH Xray will be compared with the standard HAV to see if it is accurate.
Read the detailed description
Patients going on the waiting list for TKR at our hospital will be enrolled prospectively.
Each patient will have two radiographs preoperatively. One radiograph will be the novel HKAH radiograph to measure the alignment of the heel to the whole leg and the other will be the HAV radiograph which will be used as the standard to which the HKAH measure of alignment will be compared. The HKAH radiograph will be taken instead of the standard care HKA radiograph and the HAV is additional to standard care.
Each participant will receive an information sheet along with the outpatients appointment letter which is dispatched approximately a week in advance of their appointment date. This will carry information about the study, and the risks (one additional radiograph).
Participants who are going to have a knee replacement will have a written \& informed consent to take part in the study. If they agree then they will have an additional radiograph before surgery. If they don't agree then they will have a single radiograph before surgery as is the norm in our hospital.
Whether they take part or not will have absolutely no bearing on the treatment they receive, or the aftercare.
- Conditions
- Osteoarthritis
- Being tested
- Hindfoot alignment view x ray
- Keywords
- Total knee arthroplasty, Total knee replacement, TKA, TKR
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hindfoot alignment view x rayRadiation
Diagnostic x rays used to measure leg alignment.
| Study group | Role | What they receive |
|---|---|---|
| Hindfoot alignment view x ray | Patients undergoing TKR for osteoarthritis will have an additional x ray (hindfoot alignment view) as well as the standard hip knee ankle x ray extended to include the heel. Receives: Radiation: Hindfoot alignment view x ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg alignment angle measured from the hip knee ankle heel radiograph compared to that measured from the standard hindfoot radiograph.
Leg alignment angle measured from the hip knee ankle heel radiograph compared to that measured from the standard hindfoot radiograph.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start7 Dec 2015
- Primary completion28 Jun 2016
- Study completion28 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kalpesh Shah, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583503
- Sponsor's protocol ID
- Ortho 15-09
- Status last verified
- Oct 2015
- First submitted
- 1 Sep 2015
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21120711Hara 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 25155238
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hindfoot Alignment in TKR - Validation of a Novel Radiographic Study
- ClinicalTrials.gov ID
- NCT02583503
- Acronym / sponsor ID
- Ortho 15-09
- Conditions
- Osteoarthritis
- Keywords
- Total knee arthroplasty, Total knee replacement, TKA, TKR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 28 Jun 2016 (actual)
- Study completion
- 28 Jun 2016 (actual)
- First posted
- 22 Oct 2015 (estimated)
- 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.
When carrying out a knee replacement operation one of the goals is to correct any deformity of the leg (bowlegged or knock kneed). The ideal alignment is the mechanical axis, which is a line from the centre of the hip joint to the centre of the ankle. This line indicates how the weight of the body is transmitted to the ground via the leg. Often the planning for a knee replacement uses an Xray which shows the hip, knee and ankle (HKA Xray) so that the mechanical axis can be drawn on.
However, the weight of the body goes to the ground from the ankle through the heel. There have been some reports recently suggesting that deformities in the heel can influence the overall leg alignment after a knee replacement; this may affect how successful the surgery is, or how long the knee replacement will last. Therefore it may make sense to take the alignment of the leg including the heel in planning for a knee replacement.
The conventional practice to assess the alignment of the heel is a hindfoot alignment view (HAV) Xray. This only shows the foot. Having two separate Xrays means more radiation exposure and makes linking the two alignments very difficult. We propose a single novel Xray extending the HKA Xray to shows hip, knee, ankle and heel (HKAH Xray) enabling measurement of both alignments.
This study is to validate the hindfoot alignment seen on the novel Xray with the standard HAV. Patients undergoing a knee replacement will be enrolled. Patients will have both a HKAH and HAV Xray before surgery. The alignment of the heel measured on the HKAH Xray will be compared with the standard HAV to see if it is accurate.
Detailed description
Patients going on the waiting list for TKR at our hospital will be enrolled prospectively.
Each patient will have two radiographs preoperatively. One radiograph will be the novel HKAH radiograph to measure the alignment of the heel to the whole leg and the other will be the HAV radiograph which will be used as the standard to which the HKAH measure of alignment will be compared. The HKAH radiograph will be taken instead of the standard care HKA radiograph and the HAV is additional to standard care.
Each participant will receive an information sheet along with the outpatients appointment letter which is dispatched approximately a week in advance of their appointment date. This will carry information about the study, and the risks (one additional radiograph).
Participants who are going to have a knee replacement will have a written \& informed consent to take part in the study. If they agree then they will have an additional radiograph before surgery. If they don't agree then they will have a single radiograph before surgery as is the norm in our hospital.
Whether they take part or not will have absolutely no bearing on the treatment they receive, or the aftercare.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hindfoot alignment view x ray | – | Radiation: Hindfoot alignment view x rayPatients undergoing TKR for osteoarthritis will have an additional x ray (hindfoot alignment view) as well as the standard hip knee ankle x ray extended to include the heel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for a total knee replacement at the Golden Jubilee National Hospital under the care of one of the orthopaedic consultants who have agreed to provide patients for this study.
Key inclusion criteria (3 listed)
- Predominant knee osteoarthritis requiring total knee replacement
- Able to give informed consent
- Able to return for 6 week follow-up
Key exclusion criteria (2 listed)
- Advanced osteoarthritis in other lower limb joint(s)
- limb length discrepancy requiring a shoe-raise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hindfoot alignment view x rayDiagnostic x rays used to measure leg alignment. | Radiation | Hindfoot alignment view x ray |
Primary outcome
Leg alignment angle measured from the hip knee ankle heel radiograph compared to that measured from the standard hindfoot radiograph.
Time frame: Baseline
Leg alignment angle measured from the hip knee ankle heel radiograph compared to that measured from the standard hindfoot radiograph.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- 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.
- 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.
- Individual participant dataSharing planned: No
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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.
Kalpesh Shah principal investigator
Golden Jubilee National Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Golden Jubilee National Hospital.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg alignment angle measured from the hip knee ankle heel radiograph compared to that measured from the standard hindfoot radiograph. (time frame: Baseline). 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 NCT02583503, which also lists 2 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 1 Mar 2017.