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Patient-Specific Instrumentation

Attune TruMatch (TM) for Obesity and Osteoarthritis

N/A
Waitlist Available
Led By Edward M Vasarhelyi, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up1 year, 5 years and 10 years post-operatively
Awards & highlights
No Placebo-Only Group

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You weigh more than you should for your height (BMI over 30) but less than 350 pounds.
Select...
You have knee osteoarthritis that causes severe symptoms and requires a total knee replacement surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 5 years and 10 years post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 5 years and 10 years post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of Possible Change in Radiographic Alignment
Secondary outcome measures
Assessment of Possible Change in Peri-operative metrics
Incremental cost-utility ratio
Patient-completed questionnaires

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Total Knee Arthroplasty with PSIExperimental Treatment1 Intervention
Total Knee Replacement with the use of the Attune TruMatch (TM) Patient-Specific Instrumentation
Group II: Total Knee ReplacementActive Control1 Intervention
Total Knee Replacement, as per Standard of Care

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
648 Previous Clinical Trials
411,482 Total Patients Enrolled
7 Trials studying Obesity
1,072 Patients Enrolled for Obesity
DePuy OrthopaedicsIndustry Sponsor
77 Previous Clinical Trials
25,357 Total Patients Enrolled
Johnson & Johnson Medical CompaniesIndustry Sponsor
5 Previous Clinical Trials
465 Total Patients Enrolled

Media Library

Attune TruMatch (TM) Patient-Specific Instrumentation (Patient-Specific Instrumentation) Clinical Trial Eligibility Overview. Trial Name: NCT02177227 — N/A
Obesity Research Study Groups: Total Knee Replacement, Total Knee Arthroplasty with PSI
Obesity Clinical Trial 2023: Attune TruMatch (TM) Patient-Specific Instrumentation Highlights & Side Effects. Trial Name: NCT02177227 — N/A
Attune TruMatch (TM) Patient-Specific Instrumentation (Patient-Specific Instrumentation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02177227 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for joining this medical experiment?

"According to information on clinicaltrials.gov, this trial has ceased recruitment since September 24th 2021 and is thus no longer actively seeking participants. Despite that, numerous other trials are still open for enrollment at the moment with a total of 1558 studies available."

Answered by AI

Does the protocol for this research project include individuals aged 40 or older?

"This medical trial calls for patients aged between 20 and 70, with 231 trials specifically targeting those under 18 years old and 1169 dedicated to seniors above 65."

Answered by AI

What criteria must an individual meet in order to join this inquiry?

"This research opportunity is open to 194 individuals aged 20-70 that are suffering from arthrosis. Other essential requirements include being 19-70 years old, having a BMI of between 30 and 50, and requiring total knee arthroplasty for symptom management."

Answered by AI
~13 spots leftby Aug 2024