Comparison of Multiradius and Singleradius Total Knee Arthroplasty

NCT ID: NCT04364971

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 494 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-25
• Study Completion Date: 2023-07-25

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.

Conditions

Gonarthrosis; Primary; Gonarthrosis; Gonarthrosis; Primary, Bilateral; Knee Osteoarthritis; Knee Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

singleradius and multiradius total knee arthroplasty

Intervention Type: PROCEDURE

singleradius and multiradius total knee arthroplasty

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

Group Type: EXPERIMENTAL

singleradius and multiradius total knee arthroplasty

Intervention Type: PROCEDURE

singleradius and multiradius total knee arthroplasty

Interventions

singleradius and multiradius total knee arthroplasty

singleradius and multiradius total knee arthroplasty

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Orkhan Aliyev

Resident Doctor, Department of Orthopaedics and Traumatology, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Orkhan Aliyev

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakıf University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Orkhan Aliyev

Role: CONTACT

orkhanaliyev@outlook.com.tr

00905059917419

Facility Contacts

Orkhan Aliyev

Role: primary

orkhanaliyev@outlook.com.tr

00905059917419

Nurdan Güngören

Role: backup

nurdangungoren96@gmail.com

00905543718815 ext. 00905543718815

References

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.

Reference Type: BACKGROUND

PMID: 31483401 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26614746 (View on PubMed)

Other Identifiers

259486

Identifier Type: -

Identifier Source: org_study_id