Collecting data on the Truliant Knee System after surgery

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

This study is collecting information from people who have had or will have the Truliant knee replacement to see how well it works and how safe it is after surgery.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Exactech (Industry-sponsored)
• Locations: 5 sites (Aurora, Colorado and 4 other locations)
• Trial ID: NCT05653102 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather clinical and patient outcomes data for individuals who have received or will receive the Truliant® knee prosthesis. It focuses on assessing the post-market safety and effectiveness of this orthopedic device by collecting survivorship data from both prospective and retrospective cohorts. Participants will be enrolled either before or after their knee surgery, allowing for a comprehensive analysis of outcomes associated with the Truliant® knee replacement. The study is conducted across multiple locations in the United States.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are scheduled to receive a Truliant® total knee replacement for various types of arthritis or knee conditions.

Not a fit: Patients who have already undergone knee surgery prior to enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the Truliant® knee prosthesis, potentially improving patient outcomes.

How similar studies have performed: Other studies assessing post-market outcomes of orthopedic devices have shown success, indicating that this approach is both relevant and beneficial.

Eligibility criteria

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)

Where this trial is running

Aurora, Colorado and 4 other locations

• University of Colorado Health — Aurora, Colorado, United States (Recruiting)
• Florida Research Associates — DeLand, Florida, United States (Recruiting)
• Nevada Orthopaedic and Spine Center — Las Vegas, Nevada, United States (Recruiting)
• Crystal Clinic — Akron, Ohio, United States (Recruiting)
• Medical University South Carolina — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Pearl Harris

Conditions Knee Arthroplasty, Total