Zimmer CAS PSI X-Ray Knee in TKA (Total Knee Arthroplasty)

Evaluation of Zimmer® CAS PSI X-Ray Knee in Total Knee Arthroplasty (TKA): Technical Outcomes

The objective of the observational study is to assess the positioning of customized guides designed from patients X-Rays (Zimmer® X-Ray PSI Knee) using optical navigation in primary total knee arthroplasty.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation
• Intervention / Treatment: Other: there is no intervention

Detailed Description

The proposed research is a single center, prospective, case series, and non-controlled study. One orthopedic surgeon will perform 30 primary TKAs using X-Ray PSI Knee guides, generated from X-ray. Patients who have been appropriately indicated as candidates for TKA and who meet the specified inclusion and exclusion criteria, will be informed about Zimmer® X-Ray PSI Knee technology and offered entry into the study. Informed consent, in accordance with current ethical board regulatory requirements and best practice, will be obtained from all patients.

• Study Type: Observational
• Enrollment (Actual): 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old with indication of Total Knee Arhtroplasty

Description

Inclusion Criteria:

• Male or female
• Needs a primary TKA and he/she is Persona® knee implant compatible
• Diagnosed with non-inflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.)
• Over 18 years old
• Able to:
• Understand what participation in the study entails and willing to consent (patient or his/her legal guardian) to participate in the study by signing and dating an IRB/EC approved inform consent form. and
• Follow surgeon/staff instructions, and
• Return for all follow-up evaluations, and
• Able and willing to undergo a preoperative radiographs (all cases)
• Meets an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.
• Has a presence of varus or valgus deformity of 15 degrees or less.

Exclusion Criteria:

• Is currently enrolled in an investigational new drug or device study
• Has an active infection (including septic knee, distant infection, or osteomyelitis)
• Has neurological disorders (including, but not limited to Parkinson's disease)
• Has had a prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy.
• Has hip or knee ankylosis.
• Have indications of intra- and/or extra-articular deformations that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, such as polio, history of tibial plateau fracture, etc.
• Has any metal within 150 mm of the joint line for the operative-side knee.
• Has knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination.
• Is a female who is pregnant or lactating
• Is currently involvement in any personal injury litigation, medical-legal or worker's compensation claims
• Has arterial disease or stents that would exclude the use of a tourniquet.
• Has insufficient quality or quantity of bone to support the implant due to prior knee surgery (or surgeries), cancer, metabolic bone disease, osteoporosis/osteopnea (diagnosed or treated with medication), active/old/remote infection, etc.
• Has a mental condition that may interfere with his/her ability to give an informed consent or interfere with his/her ability or willingness to fulfill the requirements of the study.
• Has a condition that would place excessive demands on the implant (e.g., Charcot's joints, muscle deficiencies, multiple joint disabilities, skeletal immaturity, etc.).
• Has collateral ligament insufficiency.
• Has an immunosuppressive disorder (e.g., AIDS, etc.) that would require cytotoxic drugs, corticosteroids, large dose of irradiation, or antilymphocytic serum.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
X-Ray PSI Group; Male or female patients, over 18 years old and with indication of total knee arthroplasty	Other: there is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
assess the positioning accuracy and precision of customized X-RAY PSI guides using the Sesamoid Optical Navigation system in Total Knee Arthroplasty	Intra-operative

Secondary Outcome Measures

Outcome Measure	Time Frame
assess the correlation between planned vs. actual component size and bony resection thickness	Intra-operative

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CSU2015-12K