NCT05653102

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
112mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2019Jul 2035

Study Start

First participant enrolled

January 23, 2019

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2035

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2035

Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

16 years

First QC Date

December 1, 2022

Last Update Submit

June 17, 2024

Conditions

Knee Arthroplasty, Total

Outcome Measures

Primary Outcomes (35)

  • 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

Study Arms (3)

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

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

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

Interventions

Truliant Total Knee SystemDEVICE

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

Prospective SubjectsRetrospective Only SubjectsRetrospective to Prospective

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Cohort 1. 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.
  • Skeletally mature (18 years of age or older).
  • Subject is willing and able to provide written informed consent for participation in the study.
  • 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.
  • The knee replacement will be performed by the investigator or a surgeon sub-investigator.
  • 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.
  • 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).
  • Skeletally mature (18 years of age or older).
  • Subject is willing and able to provide written informed consent for participation in the study.
  • 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.
  • The knee replacement was performed by the investigator or a surgeon sub-investigator.
  • The devices are/were used according to the approved indications.

You may not qualify if:

  • o 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
  • 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.
  • Skeletally mature at the time of the surgery (18 years of age or older).
  • 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.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Colorado Health

Aurora, Colorado, 80045, United States

RECRUITING

Florida Research Associates

DeLand, Florida, 32720, United States

RECRUITING

Nevada Orthopaedic and Spine Center

Las Vegas, Nevada, 89128, United States

RECRUITING

Crystal Clinic

Akron, Ohio, 44333, United States

RECRUITING

Medical University South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26833096RESULT

  • 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.

    PMID: 24623184RESULT

  • 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.

    PMID: 25818502RESULT

Central Study Contacts

Pearl Harris

CONTACT

352-327-4846pearl.harris@exac.com

Alex Knisely

CONTACT

352-377-1140alex.knisely@exac.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 16, 2022

Study Start

January 23, 2019

Primary Completion (Estimated)

January 31, 2035

Study Completion (Estimated)

July 31, 2035

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations

US(5)