Recruiting

Truliant Knee System

Sponsor:

Exactech

Code:

NCT05653102

Conditions

Knee Arthroplasty, Total

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Truliant Total Knee System

Study Details

Brief summary:

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

Conditions

Knee Arthroplasty, Total

Study ID

NCT05653102

Start date

Jan 23, 2019

Status verified date

Jun, 2024

Completion date

Jul 31, 2035

Anticipated

Primary completion date

Jan 31, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

1. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
2. Skeletally mature (18 years of age or older).
3. Subject is willing and able to provide written informed consent for participation in the study.
4. 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.
5. The knee replacement will be performed by the investigator or a surgeon sub-investigator.
6. 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.

1. 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).
2. Skeletally mature (18 years of age or older).
3. Subject is willing and able to provide written informed consent for participation in the study.
4. 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.
5. The knee replacement was performed by the investigator or a surgeon sub-investigator.
6. 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
1. Gender
2. Age at surgery
3. Height/Weight
4. Indication for surgery
5. Prior Injuries/Surgeries on index knee
6. 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.

1. Skeletally mature at the time of the surgery (18 years of age or older).
2. 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.
3. The patients clinical record includes a documented procedure that includes, or is related to, TKA with a Truliant® Knee system device.
4. The knee replacement was performed by the investigator or a surgeon sub-investigator.
5. The devices are/were used according to the approved indications.
6. 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)

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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).

Retrospective Only Subjects

Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. 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.

Interventions

Truliant Total Knee System

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

Primary outcome measure

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: Preoperative ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 1 year ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 2 year ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 3 year ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 4 year ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 5 year ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 6 year ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 7 year ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 8 year ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 9 year ]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: 10 year ]
  • Oxford Knee Score [ Time Frame: Preoperative ]
  • Oxford Knee Score [ Time Frame: 1 year ]
  • Oxford Knee Score [ Time Frame: 2 year ]
  • Oxford Knee Score [ Time Frame: 3 year ]
  • Oxford Knee Score [ Time Frame: 4 year ]
  • Oxford Knee Score [ Time Frame: 5 year ]
  • Oxford Knee Score [ Time Frame: 6 year ]
  • Oxford Knee Score [ Time Frame: 7 year ]
  • Oxford Knee Score [ Time Frame: 8 year ]
  • Oxford Knee Score [ Time Frame: 9 year ]
  • Oxford Knee Score [ Time Frame: 10 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: Preoperative ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 6-weeks ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 6-months ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 1 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 2 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 3 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 4 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 5 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 6 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 7 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 8 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 9 year ]
  • Visual Analog Scale (VAS) - Pain [ Time Frame: 10 year ]

Central Contacts and Locations

Locations

University of Colorado Health

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Michael Dayton, MD

Florida Research Associates

Recruiting

DeLand, Florida, United States, 32720

Principal Investigator:

Mark Hollmann, MD

Nevada Orthopaedic and Spine Center

Recruiting

Las Vegas, Nevada, United States, 89128

Principal Investigator:

Ronald Hillock, MD

Crystal Clinic

Recruiting

Akron, Ohio, United States, 44333

Principal Investigator:

Ian Gradisar, MD

Medical University South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Richard Friedman, MD

More Information

Sponsor

Exactech

Last update posted

Jun 18, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Exactech on 2024-06-18.