Optetrak Knee System Post Market Clinical Follow-Up

Knee Arthroplasty, Total Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788757
• Other study ID #: CR05-007
• Status: Recruiting
• Start date: June 1, 2011
• Est. completion date: June 1, 2034

Study information

• Verified date: March 2023
• Source: Exactech
• Contact: Pearl Harris
• Phone: 352-377-1140
• Email: pearl.harris[@]exac.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: June 1, 2034
• Est. primary completion date: December 31, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty, Total

Intervention

Device:
• Optetrak Total Knee System
Total Knee Arthroplasty using Exactech's Optetrak branded components.

Locations

Country	Name	City	State
United States	Medical University South Carolina	Charleston	South Carolina
United States	Nevada Orthopaedic and Spine Center	Las Vegas	Nevada
United States	Fallon Clinic	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score	(KSS) - validated outcome score	Preoperative
Primary	Knee Society Score	(KSS) - validated outcome score	6 month postoperative
Primary	Knee Society Score	(KSS) - validated outcome score	annually through study completion, maximum of 10-years
Primary	Hospital for Special Surgery Knee Score	(HSS) - validated outcome score	Preoperative
Primary	Hospital for Special Surgery Knee Score	(HSS) - validated outcome score	6 month postoperative
Primary	Hospital for Special Surgery Knee Score	(HSS) - validated outcome score	annually through study completion, maximum of 10-years
Primary	Oxford Knee Score	(OKS) - validated outcome score	Preoperative
Primary	Oxford Knee Score	(OKS) - validated outcome score	6 month postoperative
Primary	Oxford Knee Score	(OKS) - validated outcome score	annually through study completion, maximum of 10-years