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Observational Study of the Truliant Knee System

This study is collecting information on the Truliant Total Knee System, a type of knee replacement. The goal is to understand how well it works and how safe it is after people have received it. You might be able to join if you are 18 years or older, are planning to have a total knee replacement using the Truliant system, and agree to participate before your surgery. The researchers will measure your knee function and pain using a survey called the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. This will be done before your surgery, and then again one and two years later. The current recruitment status is unclear.

Study design
This is an observational study that plans to enroll 1000 participants. It is collecting data on people who have received or will receive the Truliant Total Knee System.
What's involved
You would complete a Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. survey before your surgery, and then again at one and two years after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least two years after their surgery, with assessments at one and two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05653102

A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System

Recruiting
Not specifiedAges 18+Observational
Exactech
~1,000 participants
Updated 2024-06-18 on ClinicalTrials.gov
What's tested:Truliant Total Knee System

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
Measured over Preoperative
+34 more outcomes measured

Conditions

Knee Arthroplasty, Total

Explore related trials

Total Knee Replacement

Where it's being run

5 sites across 5 states
Colorado1
Florida1
Nevada1
Ohio1
South Carolina1

Who to contact

Pearl Harris
[email protected]
352-327-4846
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Operative:
Date of Surgery
Type of Surgery (Primary / Revision)
All component product information, including catalogue reference numbers
Adverse Event Information, if applicable
Pre-Operative:
Demographic Data
Gender
Age at surgery
Height/Weight
Indication for surgery
Prior Injuries/Surgeries on index knee
Comorbidities
Operative:
Date of Surgery
Type of Surgery (Primary / Revision)
All component product information, including catalogue reference numbers Adverse Event Information, if applicable

Exclusion

Patient was \<18 years of age at time of surgery
Patient does not meet indicated population for use criteria for this device
Patient is pregnant
Patient is a prisoner
Patient has a physical or mental condition that would invalidate the results
Patient is contraindicated for the surgery (e.g., metal allergy)

What this trial measures

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.Preoperative

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.1 year

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.2 year

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.3 year

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.4 year

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.5 year

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.6 year

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.7 year

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.8 year

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.9 year

    KOOS JR. - validated outcome score

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.10 year

    KOOS JR. - validated outcome score

  • Oxford Knee ScorePreoperative

    OKS - validated outcome score

  • Oxford Knee Score1 year

    OKS - validated outcome score

  • Oxford Knee Score2 year

    OKS - validated outcome score

  • Oxford Knee Score3 year

    OKS - validated outcome score

  • Oxford Knee Score4 year

    OKS - validated outcome score

  • Oxford Knee Score5 year

    OKS - validated outcome score

  • Oxford Knee Score6 year

    OKS - validated outcome score

  • Oxford Knee Score7 year

    OKS - validated outcome score

  • Oxford Knee Score8 year

    OKS - validated outcome score

  • Oxford Knee Score9 year

    OKS - validated outcome score

  • Oxford Knee Score10 year

    OKS - validated outcome score

  • Visual Analog Scale (VAS) - PainPreoperative

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain6-weeks

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain6-months

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain1 year

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain2 year

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain3 year

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain4 year

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain5 year

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain6 year

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain7 year

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain8 year

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain9 year

    Visual scale from 1-10 (high score is better)

  • Visual Analog Scale (VAS) - Pain10 year

    Visual scale from 1-10 (high score is better)