A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA

Joint Disease Clinical Trial

Official title:

A Comparison Between 'Signature™ Personalised Patient Care' to Conventional Total Knee Arthroplasty and Computer Assisted Navigation and a Cost Benefit Analysis for the Australian Market

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145157
• Other study ID #: BMET AU03 (INT.CR.LAU3)
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: August 1, 2017
• Start date: July 2010
• Est. completion date: February 2015

Study information

• Verified date: August 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and Computer Assisted Navigation.

Description:

The objective of this study is to report and compare on the outcomes from patients undergoing total knee arthroplasty utilizing 'SignatureTM Personalised Patient Care', Conventional Total Knee Arthroplasty and Computer Assisted Navigation.

The 'SignatureTM Personalised Patient Care' is a system that uses a patient's Magnetic Resonance Imaging (MRI) and X-ray design to build surgical instruments customized for a patient's unique knee anatomy. Cutting positioning guides are produced to match the outer shape of the individual's distal femur and proximal tibia.

The cutting positioning guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is of legal age and skeletally mature

• Patient requires primary total knee arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis).

• Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk

• The patient will be available for follow up throughout the duration of the study.

Exclusion Criteria:

• Patient is unable to have an MRI scan due to the following conditions:

• Cardiac pacemaker

• Surgical clips in head (aneurysm clips)

• Some artificial heart valves

• Electronic inner ear implants

• Metal fragments in eyes

• Electronic stimulators

• Implanted pumps

• Patient has active infection or sepsis (treated or untreated)

• Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.

• Patient is female of child-bearing age and not taking contraceptive precautions.

• Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia).

• Patient has known moderate to severe renal insufficiency.

• Patient has a known or suspected metal sensitivity.

• Patient is immunosuppressed or receiving high doses of corticosteroids.

• Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.

• Patient has BMI >40.

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Intervention

Device:
• Signature Knee Guide
Total Knee Arthroplasty performed using Signature Knee Guide
• Conventional Instrumentation
Total Knee Arthroplasty performed using Conventional Instrumentation
• Computer Assisted Navigation
Total Knee Arthroplasty performed using Computer Assisted Navigation

Locations

Country	Name	City	State
Australia	Repatriation General Hospital (RGH)	Daw Park	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical Axial Alignment	The primary radiological outcome will be tibial rotation	Six months post-operative
Secondary	Functional outcomes - Knee Society Score	The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.	One year post-operative