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Comparison of Multiradius and Singleradius Total Knee Arthroplasty

Primary Purpose

Gonarthrosis; Primary, Gonarthrosis, Gonarthrosis; Primary, Bilateral

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
singleradius and multiradius total knee arthroplasty
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gonarthrosis; Primary focused on measuring multiradius, singleradius, total knee arthroplasty, sagittal patellar offset, anterior knee pain

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical and radiological diagnosis of end-stage primary gonarthrosis

Exclusion Criteria:

  • History of malignancy,
  • Severe extraarticular deformity,
  • Posttraumatic and septic arthritis sequel

Sites / Locations

  • Bezmialem Vakıf University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

singleradius

Multiradius

Arm Description

Single Radius(SR) femoral design will be perfomed to patients who is going to total knee arthroplasty. Single Radius femoral design is one of knee prosthesis' pattern which shows variation in knee kinematics

Multi Radius(MR) femoral design will be perfomed to patients who is going to total knee arthroplasty. Multi Radius femoral design is one of knee prosthesis' pattern which shows variation in knee kinematics

Outcomes

Primary Outcome Measures

anterior patellar offset ratio
The distance between the anterior cortex of the femur and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset".Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2020
Last Updated
April 30, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04364971
Brief Title
Comparison of Multiradius and Singleradius Total Knee Arthroplasty
Official Title
Comparison of Multiradius and Singleradius Prosthesis Design in Total Knee Arthroplasty Using With Association Sagittal Patellar Offset and Anterior Knee Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2020 (Anticipated)
Primary Completion Date
April 25, 2023 (Anticipated)
Study Completion Date
July 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

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
The Investigators would like to compare multiradius and single-radius total knee arthroplasty using with association between sagittal patellar offset and anterior knee pain in subjects having undergone bilateral total knee replacement.
Detailed Description
A prospective, interventional study. A total of to 494 subjects requiring bilateral multiradius( n=247) and singlerasius(n=247) knee arthroplasty will be enrolled. Anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. In addition, Visual Analogue Scale Score, Oxford Knee Score, WOMAC, SF12 and SF36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain. In the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as "femoral diameter".The remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset". Sagittal patellar offset is accepted by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis; Primary, Gonarthrosis, Gonarthrosis; Primary, Bilateral, Knee Osteoarthritis, Knee Arthritis
Keywords
multiradius, singleradius, total knee arthroplasty, sagittal patellar offset, anterior knee pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
494 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
singleradius
Arm Type
Experimental
Arm Description
Single Radius(SR) femoral design will be perfomed to patients who is going to total knee arthroplasty. Single Radius femoral design is one of knee prosthesis' pattern which shows variation in knee kinematics
Arm Title
Multiradius
Arm Type
Experimental
Arm Description
Multi Radius(MR) femoral design will be perfomed to patients who is going to total knee arthroplasty. Multi Radius femoral design is one of knee prosthesis' pattern which shows variation in knee kinematics
Intervention Type
Procedure
Intervention Name(s)
singleradius and multiradius total knee arthroplasty
Intervention Description
singleradius and multiradius total knee arthroplasty
Primary Outcome Measure Information:
Title
anterior patellar offset ratio
Description
The distance between the anterior cortex of the femur and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset".Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.
Time Frame
From the date of randimization until the final follow up of last patient, assessed up to 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical and radiological diagnosis of end-stage primary gonarthrosis Exclusion Criteria: History of malignancy, Severe extraarticular deformity, Posttraumatic and septic arthritis sequel
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orkhan Aliyev
Phone
00905059917419
Email
orkhanaliyev@outlook.com.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orkhan Aliyev
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orkhan Aliyev
Phone
00905059917419
Email
orkhanaliyev@outlook.com.tr
First Name & Middle Initial & Last Name & Degree
Nurdan Güngören
Phone
00905543718815
Ext
00905543718815
Email
nurdangungoren96@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31483401
Citation
Scott CEH, Clement ND, Yapp LZ, MacDonald DJ, Patton JT, Burnett R. Association Between Femoral Component Sagittal Positioning and Anterior Knee Pain in Total Knee Arthroplasty: A 10-Year Case-Control Follow-up Study of a Cruciate-Retaining Single-Radius Design. J Bone Joint Surg Am. 2019 Sep 4;101(17):1575-1585. doi: 10.2106/JBJS.18.01096.
Results Reference
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PubMed Identifier
26614746
Citation
Liu S, Long H, Zhang Y, Ma B, Li Z. Meta-Analysis of Outcomes of a Single-Radius Versus Multi-Radius Femoral Design in Total Knee Arthroplasty. J Arthroplasty. 2016 Mar;31(3):646-54. doi: 10.1016/j.arth.2015.10.017. Epub 2015 Oct 26.
Results Reference
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Learn more about this trial

Comparison of Multiradius and Singleradius Total Knee Arthroplasty

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