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Status unknownNCT02817737Updated Jun 29, 2016

Pre-operative Radiological Measurement to Assess Femur Rotational Alignment

An observational study in Total Knee Replacement, sponsored by Xi'an Honghui Hospital. Status unknown at 2 sites in China. Open to female participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-06-29.

Sponsored by Xi'an Honghui Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
33
Ages
40 Years to 80 Years
Sex
Female
01

Study summary

Purpose: This study outlines the benefits of the proximal tibia angle (PTA) in evaluation of the pre-operative individual condylar twist angle (CTA) in total knee arthroplasty.

Methods: Condylar twist angle and proximal tibia angle were obtained from 33 female healthy participants using computed tomography (CT). The CTA, angle between clinical transepicondylar axis and posterior condylar line were measured. The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line. The correlation between the CTA and the PTA was analyzed statistically with the linear regression.

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Conditions studied

  • Total Knee Replacement
03

In context

Lead sponsor

Xi'an Honghui Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Chinese female patients with primary varus knee OA, scheduled for primary TKAs

Inclusion criteria

  • Osteoarthritis Varus knee deformity

Exclusion criteria

Exclusion Criteria:

  • Rheumatoid arthritis valgus knee OA previous knee surgeries posttraumatic arthritis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
33 participants (estimated)
Patient registry
No

Groups and cohorts

  • CT

    Measured with computed tomography

  • plain Radiography

    Measured with plain Radiography

06

What researchers measure

Primary outcomes

  1. proximal tibia angle (PTA)

    The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line.

    Time frame: Four months

Secondary outcomes

  1. Condylar twist angle (CTA)

    The CTA is the angle between clinical transepicondylar axis and posterior condylar line

    Time frame: Four months

07

Study locations

2 of 2 sites recruiting
  • Honghui Hospital
    Xi'an, Shanxi 710054, China
    Recruiting
  • Hong-hui Hospital
    Xi'an, China
    • Qiang He, MD · Contact · 02983860818
    Recruiting
08

References and documents

Publications

  • Kanekasu K, Kondo M, Kadoya Y. Axial radiography of the distal femur to assess rotational alignment in total knee arthroplasty. Clin Orthop Relat Res. 2005 May;(434):193-7. doi: 10.1097/01.blo.0000156819.24866.8b. PubMed 15864052 ↗
  • Savin L, Botez P, Mihailescu D, Predescu V, Grierosu C. Pre-operative radiological measurement of femoral rotation for prosthetic positioning in total knee arthroplasty. Int Orthop. 2016 Sep;40(9):1855-60. doi: 10.1007/s00264-015-3110-2. Epub 2016 Jan 23. PubMed 26803321 ↗
  • Kobayashi H, Aratake M, Akamatsu Y, Mitsugi N, Taki N, Saito T. Reproducibility of condylar twist angle measurement using computed tomography and axial radiography of the distal femur. Orthop Traumatol Surg Res. 2014 Dec;100(8):885-90. doi: 10.1016/j.otsr.2014.07.025. Epub 2014 Nov 20. PubMed 25453922 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02817737
Lead sponsor
Xi'an Honghui Hospital
Responsible party
Sponsor
First posted
Jun 29, 2016
Start date
Apr 2016
Primary completion
Aug 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Jun 29, 2016

Study contacts

Qiang He, MD
Contact
heqianghonghui@163.com
13572887175
Jianbing Ma, MD
study director · Honghui Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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