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Procedure

Knee Replacement Techniques for Osteoarthritis

N/A

Recruiting

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic arthritis of the knee indicating primary total knee arthroplasty

Between the ages of 21 and 80 inclusive

Must not have

BMI >45

Neuromuscular impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Summary

This trial is looking at how different ways of aligning knee replacements during surgery can affect patient satisfaction and outcomes. The study will compare traditional mechanically aligned knee replacements with kinematically aligned knee replacements, which

Who is the study for?

This trial is for adults aged 21-80 with painful knee arthritis needing a total knee replacement. Candidates should be able to follow the study's procedures and self-evaluate their progress. They must have varus alignment (bow-leggedness) but no other details on exclusions are provided.

What is being tested?

The study tests if kinematically aligning knee implants during surgery, which respects natural leg curvature, improves patient satisfaction compared to traditional straight alignment. It uses Verasense sensors to measure pressure and balance in the knee during operation.

What are the potential side effects?

While specific side effects aren't listed, typical risks of total knee arthroplasty include pain at the surgery site, infection, blood clots, stiffness or swelling in the knee joint, and possible damage to nerves or blood vessels.

Eligibility Criteria

Inclusion Criteria

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

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I have severe knee pain that requires a total knee replacement.

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I am between 21 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is over 45.

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I have a condition that affects my muscle control.

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I have severe bone loss.

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I have a health condition that makes it hard for me to walk.

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I am younger than 21 or older than 81.

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I am unable to give my consent.

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I do not have inflammatory arthritis, posttraumatic osteoarthritis, or arthritis from sepsis.

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I have or had an infection.

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I cannot undergo major surgery due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

gait assessment

Secondary study objectives

EQ-5D patient reported outcome measure

Ligament releases

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TKA with Verasense sensorExperimental Treatment1 Intervention

Total Knee Arthroplasty (TKA) with Verasense sensor for Intraoperative Balancing: Surgeon will attempt to optimize the intraoperative pressures using the data from the Verasense sensor

Group II: Standard of Care TKAPlacebo Group1 Intervention

Standard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery

0 / 11Eligibility criteria met