RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2019-01-23

Study Completion:2035-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05653102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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: 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 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	* 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)

Inclusion Criteria

Exclusion 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.
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:
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
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

* 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)

Contacts and Locations

Study Contact

Pearl Harris

CONTACT

352-327-4846

pearl.harris@exac.com

Alex Knisely

CONTACT

352-377-1140

alex.knisely@exac.com

Study Locations (Sites)

University of Colorado Health

Aurora, Colorado, 80045

United States

Florida Research Associates

DeLand, Florida, 32720

United States

Nevada Orthopaedic and Spine Center

Las Vegas, Nevada, 89128

United States

Crystal Clinic

Akron, Ohio, 44333

United States

Medical University South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Exactech

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-23

Study Completion Date2035-07-31

Study Record Updates

Study Start Date2019-01-23

Study Completion Date2035-07-31

Terms related to this study

Additional Relevant MeSH Terms

Knee Arthroplasty, Total