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NCT Number: NCT05653102

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

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

Recruiting

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Key information

Conditions

Knee Arthroplasty, Total

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Health, Aurora, Colorado, United States

Loading trial locations.

About this study

Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cohort 1. Prospective / Subjects- Enrolled in the study pre-surgery

  • Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
  • Skeletally mature (18 years of age or older).
  • Subject is willing and able to provide written informed consent for participation in the study.
  • Subject is to receive a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.
  • The knee replacement will be performed by the investigator or a surgeon sub-investigator.
  • The devices will be used according to the approved indications.

Cohort 2. Retrospective to Prospective / Subjects enrolled in the study post- surgery then continue to participate in the study prospectively.

  • Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively).
  • Skeletally mature (18 years of age or older).
  • Subject is willing and able to provide written informed consent for participation in the study.
  • Subject received a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.
  • The knee replacement was performed by the investigator or a surgeon sub-investigator.
  • The devices are/were used according to the approved indications.
  • Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre-operative, operative, and applicable postoperative data available in the subject's medical records, related to the Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission: Pre-Operative:

o 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

Cohort 3. Retrospective Only Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Note: No prospective data may be collected from a subject if they are enrolled under this cohort unless the subject is willing and able to provide written informed consent for participation in the study.

  • Skeletally mature at the time of the surgery (18 years of age or older).
  • The patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution.
  • The patients clinical record includes a documented procedure that includes, or is related to, TKA with a Truliant® Knee system device.
  • The knee replacement was performed by the investigator or a surgeon sub-investigator.
  • The devices are/were used according to the approved indications.
  • Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria and have a minimum of the following pre-operative, operative, and applicable postoperative data available in the subject's medical records, related to the Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for submission:
  • 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 criteria

  • 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)

Treatment and study plan

Truliant Total Knee System

Device

Total Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.

Primary outcomes

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

    Time frame: Preoperative

    KOOS JR. - validated outcome score

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

    Time frame: 1 year

    KOOS JR. - validated outcome score

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

    Time frame: 2 year

    KOOS JR. - validated outcome score

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

    Time frame: 3 year

    KOOS JR. - validated outcome score

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

    Time frame: 4 year

    KOOS JR. - validated outcome score

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

    Time frame: 5 year

    KOOS JR. - validated outcome score

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

    Time frame: 6 year

    KOOS JR. - validated outcome score

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

    Time frame: 7 year

    KOOS JR. - validated outcome score

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

    Time frame: 8 year

    KOOS JR. - validated outcome score

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

    Time frame: 9 year

    KOOS JR. - validated outcome score

  11. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.

    Time frame: 10 year

    KOOS JR. - validated outcome score

  12. Oxford Knee Score

    Time frame: Preoperative

    OKS - validated outcome score

  13. Oxford Knee Score

    Time frame: 1 year

    OKS - validated outcome score

  14. Oxford Knee Score

    Time frame: 2 year

    OKS - validated outcome score

  15. Oxford Knee Score

    Time frame: 3 year

    OKS - validated outcome score

  16. Oxford Knee Score

    Time frame: 4 year

    OKS - validated outcome score

  17. Oxford Knee Score

    Time frame: 5 year

    OKS - validated outcome score

  18. Oxford Knee Score

    Time frame: 6 year

    OKS - validated outcome score

  19. Oxford Knee Score

    Time frame: 7 year

    OKS - validated outcome score

  20. Oxford Knee Score

    Time frame: 8 year

    OKS - validated outcome score

  21. Oxford Knee Score

    Time frame: 9 year

    OKS - validated outcome score

  22. Oxford Knee Score

    Time frame: 10 year

    OKS - validated outcome score

  23. Visual Analog Scale (VAS) - Pain

    Time frame: Preoperative

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

  24. Visual Analog Scale (VAS) - Pain

    Time frame: 6-weeks

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

  25. Visual Analog Scale (VAS) - Pain

    Time frame: 6-months

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

  26. Visual Analog Scale (VAS) - Pain

    Time frame: 1 year

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

  27. Visual Analog Scale (VAS) - Pain

    Time frame: 2 year

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

  28. Visual Analog Scale (VAS) - Pain

    Time frame: 3 year

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

  29. Visual Analog Scale (VAS) - Pain

    Time frame: 4 year

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

  30. Visual Analog Scale (VAS) - Pain

    Time frame: 5 year

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

  31. Visual Analog Scale (VAS) - Pain

    Time frame: 6 year

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

  32. Visual Analog Scale (VAS) - Pain

    Time frame: 7 year

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

  33. Visual Analog Scale (VAS) - Pain

    Time frame: 8 year

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

  34. Visual Analog Scale (VAS) - Pain

    Time frame: 9 year

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

  35. Visual Analog Scale (VAS) - Pain

    Time frame: 10 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Knisely

CONTACT

[email protected]

352-377-1140

Pearl Harris

CONTACT

[email protected]

352-327-4846

Sponsors and collaborators

Lead sponsor

Exactech

Industry

Registry information

Official study title

CR17-003 Truliant Knee PMCF: A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System

Important dates

Study start
2019
Primary completion
2035
Study completion
2035
First posted
Dec 16, 2022
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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