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Clinical Trials/NCT03358381
NCT03358381
Unknown
Not Applicable

The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique

Peking University People's Hospital0 sites50 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Peking University People's Hospital
Enrollment
50
Primary Endpoint
femoral component rotation
Last Updated
8 years ago

Overview

Brief Summary

Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.

Detailed Description

This is a multicenter, double-blined, randomized controled clinical trial. 98 patients from 2 clinical center will be recruited with primary knee osteoarthritis, undergoing a primary TKA. The patients will be randomly divided into two groups , the measured resection group and the gap balance group.And the gap balance technique in this study will be achieved with a ligament tensor used during TKA. Femoral component rotation will be assessed from the preoperative and postoperative CT scans.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

chenyifan

arthritis clinic and research center

Peking University People's Hospital

Eligibility Criteria

Inclusion Criteria

  • Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications

Exclusion Criteria

  • There are surgical contraindications Varus or valgus alignment exceeds 20 degrees

Outcomes

Primary Outcomes

femoral component rotation

Time Frame: 6 weeks after the surgery

The change of femoral component will be assessed through preoperation as well as postoperation CT scan for knee joint.

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