Optetrak Knee System Post Market Clinical Follow-Up

NCT05788757 | Active Not Recruiting FDA Device

• 1 other identifier: CR05-007
• Study Type: observational
• Target: 4,588
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Knee Arthroplasty, Total

Outcome Measures

Primary Outcomes (9)

• Knee Society Score

  (KSS) - validated outcome score

  Preoperative

• Knee Society Score

  (KSS) - validated outcome score

  6 month postoperative

• Knee Society Score

  (KSS) - validated outcome score

  annually through study completion, maximum of 10-years

• Hospital for Special Surgery Knee Score

  (HSS) - validated outcome score

  Preoperative

• Hospital for Special Surgery Knee Score

  (HSS) - validated outcome score

  6 month postoperative

• Hospital for Special Surgery Knee Score

  (HSS) - validated outcome score

  annually through study completion, maximum of 10-years

• Oxford Knee Score

  (OKS) - validated outcome score

  Preoperative

• Oxford Knee Score

  (OKS) - validated outcome score

  6 month postoperative

• Oxford Knee Score

  (OKS) - validated outcome score

  annually through study completion, maximum of 10-years

Study Arms (1)

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

Optetrak Total Knee System DEVICE

Total Knee Arthroplasty using Exactech's Optetrak branded components.

Enrolled Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Exactech: lead

Study Sites (3)

Fallon Clinic

Worcester, Massachusetts, 01608, United States

Location

Nevada Orthopaedic and Spine Center

Las Vegas, Nevada, 89128, United States

Location

Medical University South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Design

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

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 29, 2023
• Study Start: June 1, 2011
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): June 1, 2034
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

US (3)