Attune TruMatch (TM) Patient-Specific Instrumentation for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity+1 MoreAttune TruMatch (TM) Patient-Specific Instrumentation - Device
Eligibility
20 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the clinical outcomes and economic viability of using patient-specific instrumentation for total knee arthroplasty in obese patients.

Eligible Conditions
  • Obesity
  • Osteoarthritis

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 year, 5 years and 10 years post-operatively

Year 10
Incremental cost-utility ratio
Year 10
Assessment of Possible Change in Peri-operative metrics
Year 1
Assessment of Possible Change in Radiographic Alignment
Year 1
Patient-completed questionnaires

Trial Safety

Trial Design

2 Treatment Groups

Total Knee Replacement
1 of 2
Total Knee Arthroplasty with PSI
1 of 2

Active Control

Experimental Treatment

194 Total Participants · 2 Treatment Groups

Primary Treatment: Attune TruMatch (TM) Patient-Specific Instrumentation · No Placebo Group · N/A

Total Knee Arthroplasty with PSI
Device
Experimental Group · 1 Intervention: Attune TruMatch (TM) Patient-Specific Instrumentation · Intervention Types: Device
Total Knee ReplacementNoIntervention Group · 1 Intervention: Total Knee Replacement · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year, 5 years and 10 years post-operatively

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
614 Previous Clinical Trials
401,977 Total Patients Enrolled
7 Trials studying Obesity
1,072 Patients Enrolled for Obesity
DePuy OrthopaedicsIndustry Sponsor
77 Previous Clinical Trials
26,056 Total Patients Enrolled
Johnson & Johnson Medical CompaniesIndustry Sponsor
5 Previous Clinical Trials
465 Total Patients Enrolled
Edward M Vasarhelyi, MDPrincipal InvestigatorLondon Health Sciences Centre
1 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 20 - 70 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients who are between the ages of 19 and 70 are eligible to receive the vaccine.
were included patients who have a body mass index that is greater than 30 and less than or equal to 50 were chosen to be a part of this study.
Symptomatic knee osteoarthritis is most appropriately treated with a total knee arthroplasty.