- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02993016
Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty
Comparison of Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty: A Randomized Controlled Trial
Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving function. However, in instances where incorrect positioning and malignment of the TKA components are observed, patients can experience a range of negative postoperative outcomes such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant loosening, and eventual early revision. To avoid these complications, achieving a postoperative alignment within the range of 0°±3° of the mechanical axis is recommended. Manual intramedullary/extramedullary guides are not thought to be capable of consistently achieving axes in this range, and though computer-assisted navigation has shown superior results in comparison with conventional instrumentation, it is also limited by increased surgical times and no clear superiority in improving short-term clinical outcomes. Thus, there has been in a push in the orthopaedic community to create more precise technologies to aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation (PSI), which uses anatomical data obtained primarily from pre-operative axial computed tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs individualized to the patient's unique anatomy, was created with this goal.
This study aims to compare the clinical results of conventional and patient-specific instruments in total knee arthroplasty.
Study Overview
Status
Conditions
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 PSI would lead to a neutral mechanical axis on average more frequently than conventional instrumentation.
The study design is a double-blind randomized controlled trial. Randomly, fifty patients planed to undergo total knee arthroplasty using conventional instruments and other fifty patients undergo total knee arthroplasty using patient-specific instruments. 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 (preoperative and postoperative 6, 12, 24 months), Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior stress view on X-ray (preoperative and postoperative 6, 12, 24 months).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Youngjun Choi, MD
- Phone Number: 8258985857
- Email: wogur79@naver.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- over 19 year old
- Patients for total knee arthroplasty of both knee
- over 5 degree in lateral bowing of femur
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patient-specific instruments group
procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty.
|
|
Active Comparator: conventional instruments group
procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Range of Motion (ROM)
Time Frame: Changes from Baseline Range of Motion at postoperative 1 year
|
Changes from Baseline Range of Motion at postoperative 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
Time Frame: Changes from Baseline score to score of postoperative 1 year
|
Changes from Baseline score to score of postoperative 1 year
|
Changes in Knee Society Score
Time Frame: Changes from Baseline score to score of postoperative 1 year
|
Changes from Baseline score to score of postoperative 1 year
|
Changes in Anterior and posterior stress view on X-ray
Time Frame: Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year
|
Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- patient-specific instruments
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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