Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Patient-specific Instruments
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patient-specific instruments
The Signature™ Vanguard
conventional instruments
Vanguard PS(posterior stabilized)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Patient-specific Instruments
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patient-specific instruments group
conventional instruments group
Arm Description
procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty.
procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty.
Outcomes
Primary Outcome Measures
Changes in Range of Motion (ROM)
Secondary Outcome Measures
Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
Changes in Knee Society Score
Changes in Anterior and posterior stress view on X-ray
Full Information
NCT ID
NCT02993016
First Posted
December 8, 2016
Last Updated
December 13, 2016
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT02993016
Brief Title
Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty
Official Title
Comparison of Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty: A Randomized Controlled Trial
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
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Patient-specific Instruments
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient-specific instruments group
Arm Type
Experimental
Arm Description
procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty.
Arm Title
conventional instruments group
Arm Type
Active Comparator
Arm Description
procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty.
Intervention Type
Procedure
Intervention Name(s)
patient-specific instruments
Intervention Type
Device
Intervention Name(s)
The Signature™ Vanguard
Intervention Type
Procedure
Intervention Name(s)
conventional instruments
Intervention Type
Device
Intervention Name(s)
Vanguard PS(posterior stabilized)
Primary Outcome Measure Information:
Title
Changes in Range of Motion (ROM)
Time Frame
Changes from Baseline Range of Motion at postoperative 1 year
Secondary Outcome Measure Information:
Title
Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
Time Frame
Changes from Baseline score to score of postoperative 1 year
Title
Changes in Knee Society Score
Time Frame
Changes from Baseline score to score of postoperative 1 year
Title
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
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong In, MD, PhD
Phone
8290445228
Email
iy1000@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Youngjun Choi, MD
Phone
8258985857
Email
wogur79@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong In, MD, PhD
Organizational Affiliation
the Catholic Univerisity of Korea Seoul St Mary's hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
33794854
Citation
ALShammari SA, Choi KY, Koh IJ, Kim MS, In Y. Total knee arthroplasty in femoral bowing: does patient specific instrumentation have something to add? A randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 2;22(1):321. doi: 10.1186/s12891-021-04198-5.
Results Reference
derived
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Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty
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