Hindfoot Alignment in Total Knee Replacement

February 28, 2017 updated by: Golden Jubilee National Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

65

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Predominant knee osteoarthritis requiring total knee replacement
  • Able to give informed consent
  • Able to return for 6 week follow-up

Exclusion Criteria:

  • Advanced osteoarthritis in other lower limb joint(s)
  • limb length discrepancy requiring a shoe-raise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Radiation: Hindfoot alignment view x ray
Diagnostic x rays used to measure leg alignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golden Jubilee National Hospital

Investigators

  • Principal Investigator: Kalpesh Shah, Golden Jubilee National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2015

Primary Completion (Actual)

June 28, 2016

Study Completion (Actual)

June 28, 2016

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ortho 15-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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