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Pinless-Navigated Versus Conventional Total Knee Arthroplasty

Primary Purpose

Arthropathy of Knee

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Pinless-Navigated Total Knee Arthroplasty
Conventional Total Knee Arthroplasty
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee focused on measuring Total Knee Replacement, Computer-Assisted Surgery

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pinless-Navigated Total Knee Arthroplasty

Conventional Total Knee Arthroplasty

Arm Description

The patients underwent total knee arthroplasty using a Pinless-Navigated system that is designed to restore the mechanical alignment of the lower limb.

The patients underwent total knee arthroplasty using conventional technique.

Outcomes

Primary Outcome Measures

Radiographic analysis
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
Comparing the mean duration of surgery for both surgical arms.

Full Information

First Posted
August 3, 2012
Last Updated
April 16, 2018
Sponsor
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01676038
Brief Title
Pinless-Navigated Versus Conventional Total Knee Arthroplasty
Official Title
Radiographic Analysis Comparing Pinless-Navigated and Conventional Total Knee Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee
Keywords
Total Knee Replacement, Computer-Assisted Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pinless-Navigated Total Knee Arthroplasty
Arm Type
Active Comparator
Arm Description
The patients underwent total knee arthroplasty using a Pinless-Navigated system that is designed to restore the mechanical alignment of the lower limb.
Arm Title
Conventional Total Knee Arthroplasty
Arm Type
Active Comparator
Arm Description
The patients underwent total knee arthroplasty using conventional technique.
Intervention Type
Procedure
Intervention Name(s)
Pinless-Navigated Total Knee Arthroplasty
Intervention Description
Brainlab VectorVision Knee 2.5 Navigation System
Intervention Type
Procedure
Intervention Name(s)
Conventional Total Knee Arthroplasty
Intervention Description
Conventional technique.
Primary Outcome Measure Information:
Title
Radiographic analysis
Description
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.
Time Frame
Up till 1 year
Secondary Outcome Measure Information:
Title
Duration of surgery
Description
Comparing the mean duration of surgery for both surgical arms.
Time Frame
Up till 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pak Lin Chin, FRCS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

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Pinless-Navigated Versus Conventional Total Knee Arthroplasty

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