A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
NCT ID: NCT05653102
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2019-01-23
2035-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Truliant Total Knee System
Total Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.
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).
Truliant Total Knee System
Total Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.
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.
Truliant Total Knee System
Total Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.
Interventions
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Truliant Total Knee System
Total Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.
Eligibility Criteria
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Inclusion Criteria
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.
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.
* 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 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)
18 Years
ALL
No
Sponsors
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Exactech
INDUSTRY
Responsible Party
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Locations
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University of Colorado Health
Aurora, Colorado, United States
Florida Research Associates
DeLand, Florida, United States
Nevada Orthopaedic and Spine Center
Las Vegas, Nevada, United States
Crystal Clinic
Akron, Ohio, United States
Medical University South Carolina
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Frank Somoza
Role: primary
Diane Martin
Role: primary
Ronald Hillock, MD
Role: primary
Ginny Texter
Role: primary
Lisa Mock
Role: primary
References
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Meftah M, White PB, Ranawat AS, Ranawat CS. Long-term results of total knee arthroplasty in young and active patients with posterior stabilized design. Knee. 2016 Mar;23(2):318-21. doi: 10.1016/j.knee.2015.10.008. Epub 2016 Jan 29.
Scott CE, Clement ND, MacDonald DJ, Hamilton DF, Gaston P, Howie CR, Burnett R. Five-year survivorship and patient-reported outcome of the Triathlon single-radius total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1676-83. doi: 10.1007/s00167-014-2922-8. Epub 2014 Mar 13.
Martin A, Quah C, Syme G, Lammin K, Segaren N, Pickering S. Long term survivorship following Scorpio Total Knee Replacement. Knee. 2015 Jun;22(3):192-6. doi: 10.1016/j.knee.2015.01.007. Epub 2015 Mar 26.
Other Identifiers
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CR17-003
Identifier Type: -
Identifier Source: org_study_id
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