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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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ClinicalTrials.gov Identifier: NCT03358381
Recruitment Status : Unknown
Verified November 2017 by chenyifan, Peking University People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
chenyifan, Peking University People's Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: the gap balance type of total knee arthroplasty Procedure: the measured resection type of total knee arthroplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358381


Contacts
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Contact: Leyuan Chen 18600116051 chenleyuanqia@hotmail.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Jianhao Lin, MD arthritis clinic and research center

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Responsible Party: chenyifan, arthritis clinic and research center, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03358381     History of Changes
Other Study ID Numbers: PKUPHJSL
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by chenyifan, Peking University People's Hospital:
total knee arthroplasty
CT scan
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases