Comparison of Multiradius and Singleradius Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04364971
• Other study ID #: 259486
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 25, 2020
• Est. completion date: July 25, 2023

Study information

• Verified date: April 2020
• Source: Bezmialem Vakif University
• Contact: Orkhan Aliyev
• Phone: 00905059917419
• Email: orkhanaliyev[@]outlook.com.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 494
• Est. completion date: July 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

• Clinical and radiological diagnosis of end-stage primary gonarthrosis

Exclusion Criteria:

• History of malignancy,

• Severe extraarticular deformity,

• Posttraumatic and septic arthritis sequel

Related Conditions & MeSH terms

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

Intervention

Procedure:
• singleradius and multiradius total knee arthroplasty
singleradius and multiradius total knee arthroplasty

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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