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

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ClinicalTrials.gov Identifier: NCT02504112
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
Maisonneuve-Rosemont Hospital
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date July 17, 2015
First Posted Date July 21, 2015
Last Update Posted Date June 25, 2018
Study Start Date May 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2015)
assess the positioning accuracy and precision of customized X-RAY PSI guides using the Sesamoid Optical Navigation system in Total Knee Arthroplasty [ Time Frame: Intra-operative ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02504112 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 20, 2015)
assess the correlation between planned vs. actual component size and bony resection thickness [ Time Frame: Intra-operative ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Zimmer CAS PSI X-Ray Knee in TKA (Total Knee Arthroplasty)
Official Title Evaluation of Zimmer® CAS PSI X-Ray Knee in Total Knee Arthroplasty (TKA): Technical Outcomes
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients over 18 years old with indication of Total Knee Arhtroplasty
Condition Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation
Intervention Other: there is no intervention
Study Groups/Cohorts X-Ray PSI Group
Male or female patients, over 18 years old and with indication of total knee arthroplasty
Intervention: Other: there is no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2018)
9
Original Estimated Enrollment
 (submitted: July 20, 2015)
30
Actual Study Completion Date May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02504112
Other Study ID Numbers CSU2015-12K
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Maisonneuve-Rosemont Hospital
Investigators Not Provided
PRS Account Zimmer Biomet
Verification Date June 2018