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NCT02817737 Clinical Trial

Pre-operative Radiological Measurement to Assess Femur Rotational Alignment

Total Knee Replacement Clinical Trial

Official title:
Pre-operative Radiological Measurement of Proximal Tibia Angle to Assess Femur Rotational Alignment in Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02817737
Other study ID # XianHongHuiH
Secondary ID
Status Recruiting
Phase N/A
First received June 27, 2016
Last updated June 27, 2016
Start date April 2016
Est. completion date October 2016

Study information
Verified date June 2016
Source Xi'an Honghui Hospital
Contact Qiang He, MD
Phone 13572887175
Email heqianghonghui@163.com
Is FDA regulated No
Health authority China: Chinese Medical Association
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 33
Est. completion date October 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Osteoarthritis Varus knee deformity

Exclusion Criteria:

- Rheumatoid arthritis valgus knee OA previous knee surgeries posttraumatic arthritis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Hong-hui Hospital Xi'an
China Honghui Hospital Xi'an Shanxi

Sponsors (1)
Lead Sponsor Collaborator
Xi'an Honghui Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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 Jan 23. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary proximal tibia angle (PTA) The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line. Four months Yes
Secondary Condylar twist angle (CTA) The CTA is the angle between clinical transepicondylar axis and posterior condylar line Four months Yes
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