Pinless-Navigated Versus Conventional Total Knee Arthroplasty

NCT01676038 | Completed DMC

• 1 other identifier: 2011/519/D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee

Keywords

Total Knee Replacement, Computer-Assisted Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Up till 1 year

Secondary Outcomes (1)

• Duration of surgery

  Up till 1 year

Study Arms (2)

Pinless-Navigated Total Knee Arthroplasty

ACTIVE COMPARATOR

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

Conventional Total Knee Arthroplasty

ACTIVE COMPARATOR

The patients underwent total knee arthroplasty using conventional technique.

Procedure: Conventional Total Knee Arthroplasty

Interventions

Pinless-Navigated Total Knee Arthroplasty PROCEDURE

Brainlab VectorVision Knee 2.5 Navigation System

Pinless-Navigated Total Knee Arthroplasty

Conventional Total Knee Arthroplasty PROCEDURE

Conventional technique.

Conventional Total Knee Arthroplasty

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Study Officials

• Pak Lin Chin, FRCS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 30, 2012
• Study Start: July 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2014
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

SG (1)