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

Knee Arthroplasty, Total Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653102
• Other study ID #: CR17-003
• Status: Recruiting
• Start date: January 23, 2019
• Est. completion date: July 31, 2035

Study information

• Verified date: April 2023
• Source: Exactech
• Contact: Pearl Harris
• Phone: 352-327-4846
• Email: pearl.harris[@]exac.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 31, 2035
• Est. primary completion date: January 31, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Knee Arthroplasty, Total

Intervention

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

Locations

Country	Name	City	State
United States	Crystal Clinic	Akron	Ohio
United States	University of Colorado Health	Aurora	Colorado
United States	Medical University South Carolina	Charleston	South Carolina
United States	Florida Research Associates	DeLand	Florida
United States	Nevada Orthopaedic and Spine Center	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	Preoperative
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	1 year
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	2 year
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	3 year
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	4 year
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	5 year
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	6 year
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	7 year
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	8 year
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	9 year
Primary	Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.	KOOS JR. - validated outcome score	10 year
Primary	Oxford Knee Score	OKS - validated outcome score	Preoperative
Primary	Oxford Knee Score	OKS - validated outcome score	1 year
Primary	Oxford Knee Score	OKS - validated outcome score	2 year
Primary	Oxford Knee Score	OKS - validated outcome score	3 year
Primary	Oxford Knee Score	OKS - validated outcome score	4 year
Primary	Oxford Knee Score	OKS - validated outcome score	5 year
Primary	Oxford Knee Score	OKS - validated outcome score	6 year
Primary	Oxford Knee Score	OKS - validated outcome score	7 year
Primary	Oxford Knee Score	OKS - validated outcome score	8 year
Primary	Oxford Knee Score	OKS - validated outcome score	9 year
Primary	Oxford Knee Score	OKS - validated outcome score	10 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	Preoperative
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	6-weeks
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	6-months
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	1 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	2 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	3 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	4 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	5 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	6 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	7 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	8 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	9 year
Primary	Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (high score is better)	10 year