Study to Assess Exactech's Guided Personalized Surgery eGPS® in Total Knee Arthroplasty

NCT02962362 | Terminated

• 1 other identifier: CR15-001
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Hospital for Special Surgery knee score (HSS)

  total score, pain, function

  24 Months

• Oxford Knee Score (OKS)

  function, pain

  24 Months

• Knee Society Score (KSS)

  total score, pain, function

  24 Months

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  total score and subscales

  24 Months

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

One hundred (100) subjects enrolled up to 4 sites. All subjects will be screened, enrolled and evaluated prospectively and be followed for up to two years. In the event a subject is enrolled and does not have surgery, additional patients may be screened and enrolled to reach the 100 subjects.

You may qualify if:

• Patient requires a primary Optetrak Logic Total Knee Arthroplasty
• Patient is skeletally mature with no obvious mechanical defect
• Patient is mentally capable of completing follow-up visits
• Patient is 18 years of age or greater at time of surgery
• Patient will be available for follow-up out to 2 years
• Patient has consented to participate in the clinical study

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Exactech: lead

Study Sites (1)

Exatech, Inc.

Gainesville, Florida, 32653, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 11, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: November 1, 2021
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)