Attune With TruMatch TM Personalized Solutions Instruments

NCT02177227 | Unknown

• 1 other identifier: Attune TruMatch
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 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.

Conditions

Obesity; Osteoarthritis

Keywords

Total Knee Arthroplasty (TKA); Attune; Primary Total Knee Prosthesis; TruMatch

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

EXPERIMENTAL

Total Knee Replacement with the use of the Attune TruMatch (TM) Patient-Specific Instrumentation

Device: Attune TruMatch (TM) Patient-Specific Instrumentation

Total Knee Replacement

NO INTERVENTION

Total Knee Replacement, as per Standard of Care

Interventions

Attune TruMatch (TM) Patient-Specific Instrumentation DEVICE

Patients to receive total knee replacement with TruMatch Patient-Specific Instrumentation

Also known as: TruMatch Patient-Specific Instrumentation

Total Knee Arthroplasty with PSI

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• DePuy Orthopaedics: collaborator
• Johnson & Johnson Medical Companies: collaborator

Study Sites (1)

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Obesity; Osteoarthritis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Edward M Vasarhelyi, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

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: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)