Back to resultsOutcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Patient specific cutting guides
Standard knee cutting guides
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Total Knee Arthroplasty, Customized Cutting Block, Conventional Intramedullary Cutting Guide
Eligibility Criteria
Inclusion Criteria:
- Age 60-90
- Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
- Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
- Correction of varus or valgus.
- Willing to participate and return for follow-up study visits.
Exclusion Criteria:
- Vascular insufficiency
- Previous deep vein thrombosis and pulmonary embolism
- Previous osteotomy
- Previous patella fracture or surgery
- Previous healed tibia or femur fractures
- Previous joint replacement surgery
Sites / Locations
- Thammasat University Hospital.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard knee cutting guides
Patient specific cutting guides
Arm Description
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
Outcomes
Primary Outcome Measures
Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films
Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation
Secondary Outcome Measures
Intraoperative Bleeding
Operative time
Blood volume in suction drain
Hemoglobin level
WOMAC score
WOMAC score
WOMAC score
WOMAC score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02128464
Brief Title
Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide
Official Title
Comparison of Customized Cutting Block (Visionaire™) and Conventional Total Knee Arthroplasty: A Prospective Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.
Detailed Description
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Total Knee Arthroplasty, Customized Cutting Block, Conventional Intramedullary Cutting Guide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard knee cutting guides
Arm Type
Active Comparator
Arm Description
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
Arm Title
Patient specific cutting guides
Arm Type
Active Comparator
Arm Description
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
Intervention Type
Procedure
Intervention Name(s)
Patient specific cutting guides
Intervention Description
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
Intervention Type
Procedure
Intervention Name(s)
Standard knee cutting guides
Intervention Description
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
Primary Outcome Measure Information:
Title
Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films
Description
Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation
Time Frame
3 Months Post-operative
Secondary Outcome Measure Information:
Title
Intraoperative Bleeding
Time Frame
Intra-operative
Title
Operative time
Time Frame
During the procedure
Title
Blood volume in suction drain
Time Frame
Post-operative Day 2
Title
Hemoglobin level
Time Frame
Post-operative day1, 2, 3
Title
WOMAC score
Time Frame
6 weeks
Title
WOMAC score
Time Frame
3 Months
Title
WOMAC score
Time Frame
6 Months
Title
WOMAC score
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
WOMAC Score
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 60-90
Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
Correction of varus or valgus.
Willing to participate and return for follow-up study visits.
Exclusion Criteria:
Vascular insufficiency
Previous deep vein thrombosis and pulmonary embolism
Previous osteotomy
Previous patella fracture or surgery
Previous healed tibia or femur fractures
Previous joint replacement surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phonthakorn Panichkul, MD
Organizational Affiliation
Thammasat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thammasat University Hospital.
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
12. IPD Sharing Statement
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Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide
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