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Pinless-Navigated Versus Conventional Total Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Singapore General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jerry Chen, Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01676038
First received: August 3, 2012
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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 Intervention
Arthropathy of Knee
Procedure: Pinless-Navigated Total Knee Arthroplasty
Procedure: Conventional Total Knee Arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiographic Analysis Comparing Pinless-Navigated and Conventional Total Knee Arthroplasty: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Radiographic analysis [ Time Frame: Up till 1 year ] [ Designated as safety issue: No ]
    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:
  • Duration of surgery [ Time Frame: Up till 1 year ] [ Designated as safety issue: No ]
    Comparing the mean duration of surgery for both surgical arms.


Estimated Enrollment: 90
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pinless-Navigated TKA
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 TKA
The patients underwent total knee arthroplasty using conventional technique.
Procedure: Conventional Total Knee Arthroplasty
Conventional technique.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676038

Contacts
Contact: Jerry Chen, MBBS +6593681926 yqjchen@gmail.com

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Jerry Chen, MBBS    +65-93681926    yqjchen@gmail.com   
Sub-Investigator: Jerry Chen, MBBS         
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Pak Lin Chin, FRCS Singapore General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Jerry Chen, Dr, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01676038     History of Changes
Other Study ID Numbers: 2011/519/D
Study First Received: August 3, 2012
Last Updated: August 27, 2012
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on November 19, 2014