Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Ultra-Congruent(UC) Insert
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
total knee arthroplasty with ultra-congruent (UC) insert
total knee arthroplasty with posterior-stabilized (PS) insert
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Ultra-Congruent(UC) Insert
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultra-Congruent(UC) group
posterior-stabilized(PS) group
Arm Description
Ultra-Congruent(UC) insert will be used in total knee arthroplasty.
Posterior-stabilized(PS) insert will be used in total knee arthroplasty.
Outcomes
Primary Outcome Measures
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Secondary Outcome Measures
Change in Knee Society Score
Change in Range of Motion
Full Information
NCT ID
NCT02992613
First Posted
December 12, 2016
Last Updated
December 12, 2016
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT02992613
Brief Title
Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty
Official Title
Comparison of Ultra-Congruent(UC) and Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Ultra-Congruent(UC) Insert
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultra-Congruent(UC) group
Arm Type
Experimental
Arm Description
Ultra-Congruent(UC) insert will be used in total knee arthroplasty.
Arm Title
posterior-stabilized(PS) group
Arm Type
Active Comparator
Arm Description
Posterior-stabilized(PS) insert will be used in total knee arthroplasty.
Intervention Type
Procedure
Intervention Name(s)
total knee arthroplasty with ultra-congruent (UC) insert
Intervention Type
Procedure
Intervention Name(s)
total knee arthroplasty with posterior-stabilized (PS) insert
Primary Outcome Measure Information:
Title
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Time Frame
Change from baseline score to score of postoperative1 year
Secondary Outcome Measure Information:
Title
Change in Knee Society Score
Time Frame
Change from baseline score to score of postoperative1 year
Title
Change in Range of Motion
Time Frame
Change from baseline Range of Motion at postoperative1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
12. IPD Sharing Statement
Learn more about this trial
Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty
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