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

NCT ID: NCT03358381

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Keywords

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total knee arthroplasty CT scan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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gap balance group

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

Group Type EXPERIMENTAL

the gap balance type of total knee arthroplasty

Intervention Type PROCEDURE

A gap balance type of total knee arthroplasty surgery will be performed.The gap balance group will receive this kind of intervention.

measured resection group

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

Group Type ACTIVE_COMPARATOR

the measured resection type of total knee arthroplasty

Intervention Type PROCEDURE

A measured resection type of total knee arthroplasty surgery will be performed.The measured resection group will receive this kind of intervention.

Interventions

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the gap balance type of total knee arthroplasty

A gap balance type of total knee arthroplasty surgery will be performed.The gap balance group will receive this kind of intervention.

Intervention Type PROCEDURE

the measured resection type of total knee arthroplasty

A measured resection type of total knee arthroplasty surgery will be performed.The measured resection group will receive this kind of intervention.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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chenyifan

arthritis clinic and research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianhao Lin, MD

Role: PRINCIPAL_INVESTIGATOR

arthritis clinic and research center

Central Contacts

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Leyuan Chen

Role: CONTACT

Phone: 18600116051

Email: [email protected]

Other Identifiers

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PKUPHJSL

Identifier Type: -

Identifier Source: org_study_id