Optetrak Knee System Post Market Clinical Follow-Up

NCT ID: NCT05788757

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

4588 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-01

Study Completion Date

2034-06-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Knee Arthroplasty, Total

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Optetrak Total Knee System

Intervention Type DEVICE

Total Knee Arthroplasty using Exactech's Optetrak branded components.

Interventions

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Optetrak Total Knee System

Total Knee Arthroplasty using Exactech's Optetrak branded components.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exactech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fallon Clinic

Worcester, Massachusetts, United States

Site Status

Nevada Orthopaedic and Spine Center

Las Vegas, Nevada, United States

Site Status

Medical University South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CR05-007

Identifier Type: -

Identifier Source: org_study_id

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