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Active, not recruitingNCT05788757Updated Jun 18, 2024

Optetrak Knee System Post Market Clinical Follow-Up

An observational study in Knee Arthroplasty, Total, sponsored by Exactech. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by Exactech · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,588
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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 Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).

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Conditions studied

  • Knee Arthroplasty, Total
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In context

Lead sponsor

Exactech is the lead sponsor of 16 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients must qualify for surgery per indications and contraindications as well as meet all 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.

Inclusion criteria

  • Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
  • Patient is skeletally mature
  • Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary

Exclusion criteria

Exclusion Criteria:

  • Patient has a local or systemic infection
  • Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
  • Patient is pregnant
  • Patient has a mental or physical condition that may invalidate evaluation of the data - ---
  • Patient is a prisoner
  • Surgery is contraindicated according to the applicable product package insert
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,588 participants (estimated)
Patient registry
No

Groups and cohorts

  • Enrolled Subjects

    Patients recruited from the population undergoing knee arthroplasty as part of standard of care. Patients who meet all the inclusion criteria and none of the exclusion criteria should be presented with an opportunity to undergo the informed consent process.

    Device: Optetrak Total Knee System

Interventions

  • DeviceOptetrak Total Knee System

    Total Knee Arthroplasty using Exactech's Optetrak branded components.

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What researchers measure

Primary outcomes

  1. Knee Society Score

    (KSS) - validated outcome score

    Time frame: Preoperative

  2. Knee Society Score

    (KSS) - validated outcome score

    Time frame: 6 month postoperative

  3. Knee Society Score

    (KSS) - validated outcome score

    Time frame: annually through study completion, maximum of 10-years

  4. Hospital for Special Surgery Knee Score

    (HSS) - validated outcome score

    Time frame: Preoperative

  5. Hospital for Special Surgery Knee Score

    (HSS) - validated outcome score

    Time frame: 6 month postoperative

  6. Hospital for Special Surgery Knee Score

    (HSS) - validated outcome score

    Time frame: annually through study completion, maximum of 10-years

  7. Oxford Knee Score

    (OKS) - validated outcome score

    Time frame: Preoperative

  8. Oxford Knee Score

    (OKS) - validated outcome score

    Time frame: 6 month postoperative

  9. Oxford Knee Score

    (OKS) - validated outcome score

    Time frame: annually through study completion, maximum of 10-years

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Study locations

3 sites
  • Fallon Clinic
    Worcester, Massachusetts 01608, United States
  • Nevada Orthopaedic and Spine Center
    Las Vegas, Nevada 89128, United States
  • Medical University South Carolina
    Charleston, South Carolina 29425, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05788757
Lead sponsor
Exactech
Responsible party
Sponsor
First posted
Mar 29, 2023
Start date
Jun 1, 2011
Primary completion
Dec 31, 2033 (estimated)
Completion
Jun 1, 2034 (estimated)
Last update
Jun 18, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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