NCT04364971

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
494

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

April 25, 2020

Last Update Submit

April 30, 2020

Conditions

Gonarthrosis; PrimaryGonarthrosisGonarthrosis; Primary, BilateralKnee OsteoarthritisKnee Arthritis

Keywords

multiradiussingleradiustotal knee arthroplastysagittal patellar offsetanterior knee pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the date of randimization until the final follow up of last patient, assessed up to 15 months

Study Arms (2)

singleradius

EXPERIMENTAL

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

Multiradius

EXPERIMENTAL

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

Interventions

singleradius and multiradius total knee arthroplastyPROCEDURE

singleradius and multiradius total knee arthroplasty

Multiradiussingleradius

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and radiological diagnosis of end-stage primary gonarthrosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 31483401BACKGROUND

  • 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.

    PMID: 26614746BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Orkhan Aliyev

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Orkhan Aliyev

CONTACT

00905059917419orkhanaliyev@outlook.com.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor, Department of Orthopaedics and Traumatology, Principal Investigator

Study Record Dates

First Submitted

April 25, 2020

First Posted

April 28, 2020

Study Start

April 25, 2020

Primary Completion

April 25, 2023

Study Completion

July 25, 2023

Last Updated

May 1, 2020

Record last verified: 2020-04

Locations

TU(1)