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

Peking University

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Procedure: the measured resection type of total knee arthroplasty; Procedure: the gap balance type of total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03358381

PKUPHJSL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

gap balance group

Experimental group

Description:

The type of total knee arthroplasty will be the balance gap.The gap balance type of total knee arthroplasty will be performed.

Treatment:

Procedure: the gap balance type of total knee arthroplasty

measured resection group

Active Comparator group

Description:

The type of total knee arthroplasty will be the measured resection.The measured resection type of total knee arthroplasty will be performed.

Treatment:

Procedure: the measured resection type of total knee arthroplasty