Zimmer CAS PSI X-Ray Knee in TKA (Total Knee Arthroplasty)
Completed
- Conditions
- Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation
- Interventions
- Other: there is no intervention
- Registration Number
- NCT02504112
- Lead Sponsor
- Zimmer Biomet
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description X-Ray PSI Group there is no intervention Male or female patients, over 18 years old and with indication of total knee arthroplasty
- Primary Outcome Measures
Name Time Method 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
Name Time Method assess the correlation between planned vs. actual component size and bony resection thickness Intra-operative