Pre-operative Radiological Measurement to Assess Femur Rotational Alignment
1 other identifier
observational
33
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2016
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJune 29, 2016
June 1, 2016
4 months
June 27, 2016
June 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
proximal tibia angle (PTA)
The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line.
Four months
Secondary Outcomes (1)
Condylar twist angle (CTA)
Four months
Study Arms (2)
CT
Measured with computed tomography
plain Radiography
Measured with plain Radiography
Eligibility Criteria
Chinese female patients with primary varus knee OA, scheduled for primary TKAs
You may qualify if:
- Osteoarthritis Varus knee deformity
You may not qualify if:
- Rheumatoid arthritis valgus knee OA previous knee surgeries posttraumatic arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Honghui Hospital
Xi’an, Shanxi, 710054, China
Hong-hui Hospital
Xi'an, China
Related 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. doi: 10.1097/01.blo.0000156819.24866.8b.
PMID: 15864052BACKGROUNDSavin 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.
PMID: 26803321BACKGROUNDKobayashi 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.
PMID: 25453922BACKGROUND
Study Officials
- STUDY DIRECTOR
Jianbing Ma, MD
Honghui Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2016
First Posted
June 29, 2016
Study Start
April 1, 2016
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
June 29, 2016
Record last verified: 2016-06