Attune With TruMatch TM Personalized Solutions Instruments
1 other identifier
interventional
194
1 country
1
Brief Summary
The purpose of our study is to determine, using a prospective, randomized-controlled trial, the economic viability and clinical outcomes associated with patient-specific instrumentation (PSI) for total knee arthroplasty in an obese patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Aug 2014
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 27, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
ExpectedSeptember 18, 2026
September 1, 2026
4.8 years
June 24, 2014
September 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Possible Change in Radiographic Alignment
Mechanical axis, sagittal alignment and tibial slope are to be assessed.
Pre-operatively, 6 weeks post-operatively, 1 year post-operatively
Secondary Outcomes (3)
Assessment of Possible Change in Peri-operative metrics
1 year, 5 years and 10 years post-operatively
Patient-completed questionnaires
pre-operatively, 6 weeks, 3 months, 1 year and then once each year.
Incremental cost-utility ratio
1 year post-operatively, and each year until 10 years post-op
Study Arms (2)
Total Knee Arthroplasty with PSI
EXPERIMENTALTotal Knee Replacement with the use of the Attune TruMatch (TM) Patient-Specific Instrumentation
Total Knee Replacement
NO INTERVENTIONTotal Knee Replacement, as per Standard of Care
Interventions
Patients to receive total knee replacement with TruMatch Patient-Specific Instrumentation
Eligibility Criteria
You may qualify if:
- patients with body mass index (BMI; kg/m2) greater than 30 and less than or equal to 50
- Symptomatic knee osteoarthritis deemed most appropriately treated with total knee arthroplasty
- Patient greater than 19 and less than or equal to 70 years of age
- English-speaking
You may not qualify if:
- History of prior open knee surgery, infection, or previous knee trauma
- Simultaneous bilateral knee arthroplasty
- Underlying dementia, cognitive delay, any disorder, or geographic distance that would preclude the completion of the clinical questionnaires
- Inflammatory arthropathy
- Chronic pain syndrome
- Fibromyalgia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward M Vasarhelyi, MD
London Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic Surgeon
Study Record Dates
First Submitted
June 24, 2014
First Posted
June 27, 2014
Study Start
August 1, 2014
Primary Completion
May 6, 2019
Study Completion (Estimated)
August 1, 2028
Last Updated
September 18, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share