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

Primary Purpose

Osteoarthritis, Knee

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

the gap balance type of total knee arthroplasty

the measured resection type of total knee arthroplasty

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring total knee arthroplasty, CT scan

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gap balance group

measured resection group

Arm Description

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

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

Outcomes

Primary Outcome Measures

femoral component rotation

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03358381

First Posted

November 25, 2017

Last Updated

November 26, 2017

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03358381

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Anticipated)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

total knee arthroplasty, CT scan

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

gap balance group

Arm Type

Experimental

Arm Description

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

Arm Title

measured resection group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

the gap balance type of total knee arthroplasty

Intervention Description

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

Intervention Name(s)

the measured resection type of total knee arthroplasty

Intervention Description

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

Primary Outcome Measure Information:

Title

femoral component rotation

Description

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

Time Frame

6 weeks after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Leyuan Chen

Phone

18600116051

chenleyuanqia@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianhao Lin, MD

Organizational Affiliation

arthritis clinic and research center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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