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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
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

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

Detailed Description:
The duration of surgery and length of hospital stay were recorded for all patients. Three radiographic measurements were recorded on the coronal films: 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. The post-operative radiographic measurements were compared with the intra-operative readings from the pinless navigation system. The accepted values used in our study for normal alignment were: 1) 0° ± 3° varus/valgus for HKA; 2) perpendicular (± 3°) to the mechanical axis of the femur; 3) perpendicular (± 3°) to the mechanical axis of the tibia.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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
Conventional technique.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Duration of surgery [ Time Frame: Up till 1 year ]
    Comparing the mean duration of surgery for both surgical arms.



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 45 and 90 diagnosed with osteoarthritis of the knee and scheduled for unilateral total knee replacement.

Exclusion Criteria:

  • Patients coming for revision total knee arthroplasty
  • Patients diagnosed with inflammatory arthritis

Information from the National Library of Medicine

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


Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Pak Lin Chin, FRCS Singapore General Hospital

Additional Information:
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01676038     History of Changes
Other Study ID Numbers: 2011/519/D
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Singapore General Hospital:
Total Knee Replacement, Computer-Assisted Surgery

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases