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

NCT02504112 | Completed

• 1 other identifier: CSU2015-12K
• Study Type: observational
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• assess the correlation between planned vs. actual component size and bony resection thickness

  Intra-operative

Study Arms (1)

X-Ray PSI Group

Male or female patients, over 18 years old and with indication of total knee arthroplasty

Other: there is no intervention

Interventions

there is no intervention OTHER

X-Ray PSI Group

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 over 18 years old with indication of Total Knee Arhtroplasty

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead
• Maisonneuve-Rosemont Hospital: collaborator

Study Design

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

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 21, 2015
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 25, 2018

Record last verified: 2018-06