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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04353440
Other study ID # 19590
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 23, 2020
Est. completion date July 23, 2025

Study information

Verified date April 2020
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study to evaluate whether the position of the sagittal patellar offset is a predictive factor for anterior knee pain in subjects having undergone bilateral multiradius total knee replacement.


Description:

A prospective, observational study. A total of to 80 subjects requiring bilateral multiradius 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"[1]. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date July 23, 2025
Est. primary completion date April 23, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years to 100 Years
Eligibility Inclusion Criteria:

- Patients over 50 years of age with primary severe gonarthrosis who will undergo total knee replacement

Exclusion Criteria:

- Patients with severe gonarthrosis, with a history of malignancy, with severe extraarticular deformity, with posttraumatic and septic arthritis sequel

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

References & Publications (1)

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"[1].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. minimum 1 year
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