Collecting data on the Truliant Knee System after surgery
Official title: CR17-003 Truliant Knee PMCF: A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
Run by Exactech · NCT05653102 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Exactech Industry-sponsored |
| Locations | 5 sites (Aurora, Colorado and 4 other locations) |
| Status | Recruiting |
| Started | January 23, 2019 |
| Main results expected | January 31, 2035 |
| Study ends | July 31, 2035 |
| Registry record updated | June 18, 2024 |
| Trial ID | NCT05653102 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who have already undergone knee surgery prior to enrollment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies assessing post-market outcomes of orthopedic devices have shown success, indicating that this approach is both relevant and beneficial.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: pearl.harris@exac.com
- Phone: 352-327-4846
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Adductor canal block versus adductor canal plus IPACK block for pain after total knee replacement
This study will test whether adding an IPACK block to an adductor canal block reduces pain and the need for pain medicine after total knee replacement.
-
12-month effects of keeping the posterior cruciate ligament during MAKO robotic-assisted total knee replacement
This trial tests whether keeping the posterior cruciate ligament during MAKO robotic-assisted total knee replacement leads to better function at 12 months for people having a first-time unilateral knee replacement.
-
Post-Operative Pain Relief with Zynrelef vs Periarticular Injections in Robot-Assisted Knee Replacement
This study tests whether the Zynrelef extended-release periarticular injection can reduce pain and opioid use after robot-assisted total knee arthroplasty compared with standard periarticular injections.
-
Cryoneurolysis before total knee replacement surgery
This trial will test whether freezing the genicular nerves at least 24 hours before total knee replacement reduces long-term pain and improves recovery for adults having primary TKA for osteoarthritis.
-
Types of persistent pain after hip or knee replacement
We will re-contact people who still have moderate-to-severe pain after hip or knee replacement to see whether their pain shows signs of nociceptive, neuropathic, or nociplastic mechanisms.
-
Low-dose epinephrine with tranexamic acid during knee replacement
This will test whether giving low-dose epinephrine together with tranexamic acid to people having knee replacement reduces blood loss, clotting complications, and hospital stay.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.