Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty

NCT02230215 | Completed

• 1 other identifier: 105453
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging to determine whether patient-specific instrumentation for total knee arthroplasty (replacement) has an effect on implant loosening compared to conventional instrumentation. Secondary objectives will include assessment of post-operative implant alignment, patient satisfaction, operative time and surgical instrument use, cost, and environmental impact.

Conditions

Osteoarthritis

Keywords

Total Knee Replacement; Visionaire

Outcome Measures

Primary Outcomes (1)

• Evaluating the Change in Implant Fixation assessed using RSA imaging

  Model based RSA will be used to measure the migration of the implant components relative to the bone between all time points.

  2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years

Secondary Outcomes (1)

• Patient Outcomes including Satisfaction

  Preoperatively, 1 year, 2 year

Other Outcomes (2)

• Component Alignment

  1 year, 2 year

• Cost

  Intraoperatively

Study Arms (2)

Patient-Specific Instrumentation

EXPERIMENTAL

Patients to have a total knee replacement surgery completed using Patient-Specific Instrumentation

Device: Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation

Traditional Instrumentation

NO INTERVENTION

Patients to have a total knee replacement surgery done using traditional instrumentation.

Interventions

Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation DEVICE

The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.

Also known as: Visionaire Patient Specific Instrumentation

Patient-Specific Instrumentation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing primary total knee replacement surgery
• No previous knee hardware (ie.Uni-Knees, or high tibial osteotomy)
• BMI \< 40
• Study patients should live within 100 km of our facility to ensure availability for follow-up

You may not qualify if:

• Pregnancy or considering pregnancy
• BMI \> 40
• Unable to undergo MRI screening

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Orthopaedic Foundation: collaborator
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

University Hospital

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Douglas Naudie, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: September 3, 2014
• Study Start: June 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 8, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)