Hindfoot Alignment in Total Knee Replacement

NCT02583503 | Completed DMC

• 1 other identifier: Ortho 15-09
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Osteoarthritis

Keywords

Total knee arthroplasty; Total knee replacement; TKA; TKR

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (1)

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

Interventions

Hindfoot alignment view x ray RADIATION

Diagnostic x rays used to measure leg alignment.

Hindfoot alignment view x ray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead

Related Publications (2)

• 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: 21120711 BACKGROUND

• 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: 25155238 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kalpesh Shah

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: October 22, 2015
• Study Start: December 7, 2015
• Primary Completion: June 28, 2016
• Study Completion: June 28, 2016
• Last Updated: March 1, 2017

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share