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Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty

Comparison of Ultra-Congruent(UC) and Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02992613
Enrollment
100
Registered
2016-12-14
Start date
2016-12-31
Completion date
2018-12-31
Last updated
2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Ultra-Congruent(UC) Insert

Brief summary

Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS) total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty has been postulated to provide reproducible femoral rollback and increased flexion. However, posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to several post-cam related problems, including post-cam dislocation, wear and breakage of post, and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone resection and poses a risk for intercondylar fracture of the distal femur during box preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent (UC) total knee arthroplasty was introduced. This study aims to compare the clinical results of Ultra-Congruent(UC) and posterior-stabilized(PS) insert in bilateral total knee arthroplasty.

Detailed description

The objective of this work was to compare pain, stiffness, function and accuracy between groups at minimum 2 year postoperatively. The investigators hypothesized that the Ultra-Congruent(UC) insert would provide similar functional outcomes without increasing the incidence of adverse events. The study design is a double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously bilateral total knee arthroplasty are randomised to be used Ultra-Congruent(UC) insert on one leg and posterior-stabilized(PS) insert on the other. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index ) pain scale, Knee Society Score, Anterior and posterior stress view on X-ray.

Interventions

PROCEDUREtotal knee arthroplasty with ultra-congruent (UC) insert
PROCEDUREtotal knee arthroplasty with posterior-stabilized (PS) insert

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* over 19 year old * Patients for total knee arthroplasty of both knee * having medicare insurance

Exclusion criteria

* Rheumatoid arthritis * Other inflammatory arthritis * Neuropsychiatric patients * Hepatic insufficiency * Renal insufficiency * over 40 of body mass index * Chronic opioid use (taking opioids for longer than 3 months)

Design outcomes

Primary

MeasureTime frame
Change in Western Ontario and McMaster Universities Index(WOMAC index)Change from baseline score to score of postoperative1 year

Secondary

MeasureTime frame
Change in Knee Society ScoreChange from baseline score to score of postoperative1 year
Change in Range of MotionChange from baseline Range of Motion at postoperative1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026