Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical NavigationNCT02504112
Zimmer CAS PSI X-Ray Knee in TKA (Total Knee Arthroplasty)
An observational study of Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation, run by Zimmer Biomet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old with indication of Total Knee Arhtroplasty
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation
- Being tested
- there is no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| X-Ray PSI Group | Male or female patients, over 18 years old and with indication of total knee arthroplasty Receives: Other: there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the positioning accuracy and precision of customized X-RAY PSI guides using the Sesamoid Optical Navigation system in Total Knee Arthroplasty
Measured: Intra-operative
Secondary outcomes (1)
assess the correlation between planned vs. actual component size and bony resection thickness
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startMay 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical NavigationStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maisonneuve-Rosemont Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504112
- Sponsor's protocol ID
- CSU2015-12K
- Status last verified
- Jun 2018
- First submitted
- 17 Jul 2015
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Zimmer® CAS PSI X-Ray Knee in Total Knee Arthroplasty (TKA): Technical Outcomes
- ClinicalTrials.gov ID
- NCT02504112
- Acronym / sponsor ID
- CSU2015-12K
- Conditions
- Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Maisonneuve-Rosemont Hospital
- Study start
- May 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X-Ray PSI Group | – | Other: there is no interventionMale or female patients, over 18 years old and with indication of total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old with indication of Total Knee Arhtroplasty
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there is no intervention | Other | X-Ray PSI Group |
Primary outcome
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
1 secondary outcome
assess the correlation between planned vs. actual component size and bony resection thickness
Time frame: Intra-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation, run by Zimmer Biomet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.