Comparison of Multiradius and Singleradius Total Knee Arthroplasty

April 30, 2020 updated by: Orkhan Aliyev, Bezmialem Vakif University

Comparison of Multiradius and Singleradius Prosthesis Design in Total Knee Arthroplasty Using With Association Sagittal Patellar Offset and Anterior Knee Pain

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

494

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical and radiological diagnosis of end-stage primary gonarthrosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: singleradius
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
Procedure: singleradius and multiradius total knee arthroplasty
singleradius and multiradius total knee arthroplasty
Experimental: Multiradius
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
Procedure: singleradius and multiradius total knee arthroplasty
singleradius and multiradius total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anterior patellar offset ratio
Time Frame: From the date of randimization until the final follow up of last patient, assessed up to 15 months
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.
From the date of randimization until the final follow up of last patient, assessed up to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Orkhan Aliyev, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 25, 2020

Primary Completion (Anticipated)

April 25, 2023

Study Completion (Anticipated)

July 25, 2023

Study Registration Dates

First Submitted

April 25, 2020

First Submitted That Met QC Criteria

April 25, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 259486

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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