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Patient-Specific Instrumentation

Patient-Specific Knee Surgery for 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

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

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

Who is the study for?

This trial is for English-speaking adults aged 19-70 with obesity (BMI between 30 and 50) who have knee osteoarthritis best treated by total knee replacement. It's not for those with prior open knee surgery, infections, trauma, cognitive issues that affect questionnaire completion, inflammatory joint diseases, plans for bilateral knee replacements at once, fibromyalgia or chronic pain syndrome.Check my eligibility

What is being tested?

The study is testing the economic and clinical effectiveness of Attune TruMatch Personalized Solutions Instruments in performing total knee replacements in obese patients. This involves comparing patient-specific instrumentation to standard methods using a randomized-controlled approach.See study design

What are the potential side effects?

While specific side effects are not listed here as it's an instrument being tested rather than a drug, potential risks may include typical surgical complications such as infection, bleeding, blood clots or issues related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have knee pain from arthritis and need a knee replacement.

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I am between 20 and 70 years old.

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My BMI is between 30 and 50.

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,234 Total Patients Enrolled

7 Trials studying Obesity

1,072 Patients Enrolled for Obesity

DePuy OrthopaedicsIndustry Sponsor

79 Previous Clinical Trials

25,645 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.

All > Obesity > Osteoarthritis