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Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Distal femoral resection in total knee arthroplasty
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring extramedullary, intramedullary, total knee arthroplasty (TKA)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Varus knee; degrees of extra articular deformity < 15°; Knee Osteoarthritis; Straight limited < 30°; range of knee flexion > 90°; No hip abnormalities

Exclusion Criteria:

  • Valgus knee; degrees of extra articular deformity > 15°; Knee infection; Rheumatic arthritis; Ankylosing Spondylitis; Prior femoral surgery

Sites / Locations

  • Zhihong XuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Male Extramedullary

Female Extramedullary

Male Intramedullary

Female Intramedullary

Arm Description

In this group, patients are male and femoral extramedullary resection would be used.

In this group, patients are female and femoral extramedullary resection would be used.

In this group, patients are male and femoral Intramedullary resection would be used.

In this group, patients are female and femoral Intramedullary resection would be used.

Outcomes

Primary Outcome Measures

Imaging tests
Evaluate the X-ray changes. Measuring the hip-knee-ankle (HKA) angle by x-ray films
Assess the changes of KSS scores
KSS scores will be recorded.
Assess the changes of SF-36 scores
SF-36 scores will be recorded
Assess the changes of WOMAC scores
WOMAC scores will be recorded.

Secondary Outcome Measures

deep vein thrombosis (DVT)
DVT was diagnosed by 3 experienced radiologists 96 according to Robinov group's criterion.
Range of knee motion
Range of knee motion will be recorded.

Full Information

First Posted
March 6, 2017
Last Updated
April 11, 2018
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03085121
Brief Title
Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty
Official Title
A Comparative Study of Femoral Extramedullary and Intramedullary Alignment Systems in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective study will be performed to compare the clinical outcome after total knee arthroplasty (TKA) using two different alignment systems: an extramedullary system versus an intramedullary system. The extramedullary femoral alignment system is newly designed. These two systems are used to make the distal femoral resection in 100 patients in a random order.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
extramedullary, intramedullary, total knee arthroplasty (TKA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Male Extramedullary
Arm Type
Experimental
Arm Description
In this group, patients are male and femoral extramedullary resection would be used.
Arm Title
Female Extramedullary
Arm Type
Experimental
Arm Description
In this group, patients are female and femoral extramedullary resection would be used.
Arm Title
Male Intramedullary
Arm Type
Active Comparator
Arm Description
In this group, patients are male and femoral Intramedullary resection would be used.
Arm Title
Female Intramedullary
Arm Type
Active Comparator
Arm Description
In this group, patients are female and femoral Intramedullary resection would be used.
Intervention Type
Procedure
Intervention Name(s)
Distal femoral resection in total knee arthroplasty
Intervention Description
EM and IM alignment systems are used to make the distal femoral cut in a random order.
Primary Outcome Measure Information:
Title
Imaging tests
Description
Evaluate the X-ray changes. Measuring the hip-knee-ankle (HKA) angle by x-ray films
Time Frame
pre surgery and 3, 12 months post surgery
Title
Assess the changes of KSS scores
Description
KSS scores will be recorded.
Time Frame
pre surgery and 3, 12 months post surgery
Title
Assess the changes of SF-36 scores
Description
SF-36 scores will be recorded
Time Frame
pre surgery and 3, 12 months post surgery
Title
Assess the changes of WOMAC scores
Description
WOMAC scores will be recorded.
Time Frame
pre surgery and 3, 12 months post surgery
Secondary Outcome Measure Information:
Title
deep vein thrombosis (DVT)
Description
DVT was diagnosed by 3 experienced radiologists 96 according to Robinov group's criterion.
Time Frame
pre surgery and 3, 12 months post surgery
Title
Range of knee motion
Description
Range of knee motion will be recorded.
Time Frame
pre surgery and 3, 12 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Varus knee; degrees of extra articular deformity < 15°; Knee Osteoarthritis; Straight limited < 30°; range of knee flexion > 90°; No hip abnormalities Exclusion Criteria: Valgus knee; degrees of extra articular deformity > 15°; Knee infection; Rheumatic arthritis; Ankylosing Spondylitis; Prior femoral surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Jiang, PhD
Phone
+8613605192953
Email
qingj@nju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihong Xu, PhD
Phone
+8613912988032
Email
xuzhihongjoint@hotmail.com
Facility Information:
Facility Name
Zhihong Xu
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihong Xu, Ph.D
Email
xuzhihongjoint@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sheng Zhou, Ph.D
Email
zhousheng0719@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21575792
Citation
Meding JB, Berend ME, Ritter MA, Galley MR, Malinzak RA. Intramedullary vs extramedullary femoral alignment guides: a 15-year follow-up of survivorship. J Arthroplasty. 2011 Jun;26(4):591-5. doi: 10.1016/j.arth.2010.05.008.
Results Reference
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PubMed Identifier
22610529
Citation
Nakahara H, Matsuda S, Okazaki K, Tashiro Y, Iwamoto Y. Sagittal cutting error changes femoral anteroposterior sizing in total knee arthroplasty. Clin Orthop Relat Res. 2012 Dec;470(12):3560-5. doi: 10.1007/s11999-012-2397-1. Epub 2012 May 19.
Results Reference
background
PubMed Identifier
24912573
Citation
Kim CW, Seo SS, Kim JH, Lee HJ, Lee CR. Factors affecting the osteolysis around the components after posterior-stabilized total knee replacement arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1863-9. doi: 10.1007/s00167-014-3088-0. Epub 2014 Jun 11.
Results Reference
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Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

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