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

• Sponsor: Exactech (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05653102
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 5
• Anticipated Duration (Months): 198.2
• Patients Per Site: 200
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Knee Arthroplasty, Total	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 Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CR17-003 Truliant Knee PMCF: A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
• Actual Study Start Date: Jan 23, 2019
• Anticipated Primary Completion Date: Jan 31, 2035
• Anticipated Study Completion Date: Jul 31, 2035

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [Preoperative]

   KOOS JR. - validated outcome score

2. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [1 year]

   KOOS JR. - validated outcome score

3. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [2 year]

   KOOS JR. - validated outcome score

4. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [3 year]

   KOOS JR. - validated outcome score

5. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [4 year]

   KOOS JR. - validated outcome score

6. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [5 year]

   KOOS JR. - validated outcome score

7. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [6 year]

   KOOS JR. - validated outcome score

8. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [7 year]

   KOOS JR. - validated outcome score

9. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [8 year]

   KOOS JR. - validated outcome score

10. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [9 year]

    KOOS JR. - validated outcome score

11. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [10 year]

    KOOS JR. - validated outcome score

12. Oxford Knee Score [Preoperative]

    OKS - validated outcome score

13. Oxford Knee Score [1 year]

    OKS - validated outcome score

14. Oxford Knee Score [2 year]

    OKS - validated outcome score

15. Oxford Knee Score [3 year]

    OKS - validated outcome score

16. Oxford Knee Score [4 year]

    OKS - validated outcome score

17. Oxford Knee Score [5 year]

    OKS - validated outcome score

18. Oxford Knee Score [6 year]

    OKS - validated outcome score

19. Oxford Knee Score [7 year]

    OKS - validated outcome score

20. Oxford Knee Score [8 year]

    OKS - validated outcome score

21. Oxford Knee Score [9 year]

    OKS - validated outcome score

22. Oxford Knee Score [10 year]

    OKS - validated outcome score

23. Visual Analog Scale (VAS) - Pain [Preoperative]

    Visual scale from 1-10 (high score is better)

24. Visual Analog Scale (VAS) - Pain [6-weeks]

    Visual scale from 1-10 (high score is better)

25. Visual Analog Scale (VAS) - Pain [6-months]

    Visual scale from 1-10 (high score is better)

26. Visual Analog Scale (VAS) - Pain [1 year]

    Visual scale from 1-10 (high score is better)

27. Visual Analog Scale (VAS) - Pain [2 year]

    Visual scale from 1-10 (high score is better)

28. Visual Analog Scale (VAS) - Pain [3 year]

    Visual scale from 1-10 (high score is better)

29. Visual Analog Scale (VAS) - Pain [4 year]

    Visual scale from 1-10 (high score is better)

30. Visual Analog Scale (VAS) - Pain [5 year]

    Visual scale from 1-10 (high score is better)

31. Visual Analog Scale (VAS) - Pain [6 year]

    Visual scale from 1-10 (high score is better)

32. Visual Analog Scale (VAS) - Pain [7 year]

    Visual scale from 1-10 (high score is better)

33. Visual Analog Scale (VAS) - Pain [8 year]

    Visual scale from 1-10 (high score is better)

34. Visual Analog Scale (VAS) - Pain [9 year]

    Visual scale from 1-10 (high score is better)

35. Visual Analog Scale (VAS) - Pain [10 year]

    Visual scale from 1-10 (high score is better)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Health	Aurora	Colorado	United States	80045
2	Florida Research Associates	DeLand	Florida	United States	32720
3	Nevada Orthopaedic and Spine Center	Las Vegas	Nevada	United States	89128
4	Crystal Clinic	Akron	Ohio	United States	44333
5	Medical University South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Exactech

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Exactech
• ClinicalTrials.gov Identifier: NCT05653102
• Other Study ID Numbers: CR17-003 Truliant Knee PMCF
• First Posted: Dec 16, 2022
• Last Update Posted: Dec 16, 2022
• Last Verified: Dec 1, 2022

• 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

Study Results

No Results Posted as of Dec 16, 2022