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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year, 5 years and 10 years post-operatively

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

0 / 2Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

Attune With TruMatch TM Personalized Solutions Instruments

Edward Vasarhelyi 2014. "Attune With TruMatch TM Personalized Solutions Instruments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02177227.

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