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

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

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

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Device: Truliant Total Knee System

Detailed 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).

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Pearl Harris; Phone Number: 352-327-4846; Email: pearl.harris@exac.com
• Study Contact Backup: Name: Alex Knisely; Phone Number: 352-377-1140; Email: alex.knisely@exac.com

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Health
      • Contact: Frank Somoza
      • Principal Investigator: Michael Dayton, MD
  • Florida
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Florida Research Associates
      • Contact: Diane Martin
      • Principal Investigator: Mark Hollmann, MD
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Recruiting
      • Nevada Orthopaedic and Spine Center
      • Contact: Ronald Hillock, MD
      • Principal Investigator: Ronald Hillock, MD
  • Ohio
    • Akron, Ohio, United States, 44333
      • Recruiting
      • Crystal Clinic
      • Contact: Ginny Texter
      • Principal Investigator: Ian Gradisar, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University South Carolina
      • Contact: Lisa Mock
      • Principal Investigator: Richard Friedman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The Truliant® Femoral Components, Tibial Inserts, Patellar Component and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Truliant® Cemented Femoral Components, Tibial Inserts, Patellar Component and Tibial Trays are indicated for cemented use only. The Truliant® Porous Femoral Components are indicated for cemented or cementless use. The Truliant® Porous Tibial Trays are indicated for cemented or cementless use.

Patients must qualify for surgery per indications and contraindications as well as meet all of the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the discretion of the surgeon.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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).	Device: 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.	Device: Truliant Total Knee System; Total Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Exactech

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Estimated): January 31, 2035
• Study Completion (Estimated): July 31, 2035

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CR17-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes