CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
Vanguard® Knee Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04419311
NCT04419311N/ACompleted

Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties: A Randomized Controlled Trial

Aksaray University Training and Research Hospital·interventional·Posted Jun 5, 2020·Updated Mar 16, 2021

In Brief

A clinical study evaluating Vanguard® Knee System for Osteoarthritis, Knee and Knee Arthritis. Completed, enrolled 66 participants across 1 site.

Detailed Summary

The choice between ultra-congruent (UC) insert or posterior cruciate ligament-stabilized (PS) insert in posterior cruciate ligament (PCL) sacrificing total knee arthroplasty (TKA) remains debatable. Despite the potential advantages of the UC insert over PS insert with its different design, there are concerns about inferior clinical outcome related to its use. Therefore, isokinetic performance was used in this study to objectively evaluate knee function after TKA and the clinical scores of the patients were also evaluated. To the best of our knowledge, no prospective randomized study has compared the isokinetic performance of the knee following the use of UC and PS inserts in TKA. The hypothesis of the present study was that compared with the PS insert, the UC insert would be associated with a lower clinical outcome and isokinetic performance following TKA. A total of 65 patients scheduled to undergo TKA on for primary knee osteoarthritis were randomly assigned to either the UC (32 patients) or the PS group (33 patients). The Knee Society Score (KSS) and isokinetic performance results of each patient were recorded preoperatively and at postoperative 3, 6 and 12 months. The physiatrist performing isokinetic tests and patients were blinded to the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 5, 2020
Enrollment StartJan 19, 2017
Primary CompletionMar 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.1 years ago

Interventions

Vanguard® Knee Systemdevice

Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.