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Active, Not Recruiting

NCT Number: NCT05788757

Optetrak Knee System Post Market Clinical Follow-Up

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Arthroplasty, Total

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fallon Clinic, Worcester, Massachusetts, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Optetrak Total Knee System

Device

Total Knee Arthroplasty using Exactech's Optetrak branded components.

Primary outcomes

  1. Knee Society Score

    Time frame: Preoperative

    (KSS) - validated outcome score

  2. Knee Society Score

    Time frame: 6 month postoperative

    (KSS) - validated outcome score

  3. Knee Society Score

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

    (KSS) - validated outcome score

  4. Hospital for Special Surgery Knee Score

    Time frame: Preoperative

    (HSS) - validated outcome score

  5. Hospital for Special Surgery Knee Score

    Time frame: 6 month postoperative

    (HSS) - validated outcome score

  6. Hospital for Special Surgery Knee Score

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

    (HSS) - validated outcome score

  7. Oxford Knee Score

    Time frame: Preoperative

    (OKS) - validated outcome score

  8. Oxford Knee Score

    Time frame: 6 month postoperative

    (OKS) - validated outcome score

  9. Oxford Knee Score

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

    (OKS) - validated outcome score

Sponsors and collaborators

Lead sponsor

Exactech

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2033
Study completion
2034
First posted
Mar 29, 2023
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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