Pinless-Navigated Versus Conventional Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT01676038|
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : April 18, 2018
The success of total knee arthroplasty depends on a number of factors including pre-operative range of movement, obesity, medical comorbidities, prosthesis design, preparation and implantation of the prosthesis, soft tissue balancing, as well as implants alignment. Optimal placement of the implants within 3° of the mechanical axis of the lower limb has been proven to reduce wear and early implant failure.
Compared to conventional techniques, computer-Aided Navigation total knee arthroplasty has been widely used in the last decade and have been proven to improve the accuracy of prosthesis placement and lower limb alignment by reducing the number of outliers with more than 3° deviation from the mechanical axis. However, its use also involves a steep learning curve, high initial capital cost and longer duration of surgery.
Traditional computer-navigated TKA using optical tracking systems also requires fixation of the femoral and tibial reference arrays to bone using anchoring pins. Complications reported with the use of these pins include either femoral or tibial fracture, pin site pain, pin site infection and osteomyelitis. The investigators study aims to investigate the accuracy of a new pinless navigation system for TKA that will avoid these complications.
|Condition or disease||Intervention/treatment||Phase|
|Arthropathy of Knee||Procedure: Pinless-Navigated Total Knee Arthroplasty Procedure: Conventional Total Knee Arthroplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Radiographic Analysis Comparing Pinless-Navigated and Conventional Total Knee Arthroplasty: A Randomized Controlled Trial|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||August 2014|
Active Comparator: Pinless-Navigated Total Knee Arthroplasty
The patients underwent total knee arthroplasty using a Pinless-Navigated system that is designed to restore the mechanical alignment of the lower limb.
Procedure: Pinless-Navigated Total Knee Arthroplasty
Brainlab VectorVision Knee 2.5 Navigation System
Active Comparator: Conventional Total Knee Arthroplasty
The patients underwent total knee arthroplasty using conventional technique.
Procedure: Conventional Total Knee Arthroplasty
- Radiographic analysis [ Time Frame: Up till 1 year ]The number of outliers and mean value of: 1) Hip-Knee-Ankle Angle (HKA), the angle formed by the mechanical axis of the femur (line between the centre of the femoral head and the centre of the knee) and the mechanical axis of the tibia (line between the centre of the talus and the centre of the knee); 2) Coronal Femoral-Component Angle (CFA), the angle formed by the femoral component and the mechanical axis of the femur; 3) Coronal Tibia-Component Angle (CTA), the angle formed by the tibia base plate and the mechanical axis of the tibia.
- Duration of surgery [ Time Frame: Up till 1 year ]Comparing the mean duration of surgery for both surgical arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676038
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Pak Lin Chin, FRCS||Singapore General Hospital|