Comparison of Multiradius and Singleradius Total Knee Arthroplasty

Not Applicable

• Conditions: Gonarthrosis; Primary, Bilateral; Knee Osteoarthritis; Gonarthrosis; Primary; Knee Arthritis; Gonarthrosis
• Interventions: Procedure: singleradius and multiradius total knee arthroplasty

• Registration Number: NCT04364971
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-25
• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-01
• Primary Completion: 2023-04-25
• Study Completion: 2023-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 494

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
singleradius	singleradius and multiradius total knee arthroplasty	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
Multiradius	singleradius and multiradius total knee arthroplasty	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

Primary Outcome Measures

Name	Time	Method
anterior patellar offset ratio	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.

Trial Locations

Locations (1)

Bezmialem Vakıf University; 🇹🇷 Istanbul, Turkey