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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

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.

Condition or disease Intervention/treatment
Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation 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.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Zimmer® CAS PSI X-Ray Knee in Total Knee Arthroplasty (TKA): Technical Outcomes
Study Start Date : May 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. assess the correlation between planned vs. actual component size and bony resection thickness [ Time Frame: Intra-operative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 18 years old with indication of Total Knee Arhtroplasty
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.

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02504112     History of Changes
Other Study ID Numbers: CSU2015-12K
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018