Arthritis Knee
Conditions
Keywords
total knee arthroplasty, PersonaIQ
Brief summary
The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.
Detailed description
The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe).
Interventions
OTHERClinical Limping Evalution
Patients will be asked to perform a Clinical Limping Evaluation in the clinic during their post-operative follow-up visit. This will be performed in a controlled environment within the physician's clinic. Each patient will be asked to walk at their normal walking speed down a hallway for at least 7 consecutive steps and back toward the physician. Walking down the hallway and back is one walking trial. Each patient will be asked to perform 2 walking trials. The health care provider will assess the patient's limp using a 3-point Likert scale (0=No limp, 1=mild/moderate limp, 2=severe limp). If required, patients may use an assistive device and the type of device should be documented. If a patient requires assistance, only the minimum amount of assistance required for a patient to complete the task should be provided.
Sponsors
Canary Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Patient must be 18 years of age or older * Independent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labeling * Patient must be willing and able to complete the protocol required follow-up * Patient has participated in the study-related informed consent process * Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent
Exclusion criteria
* • Simultaneous bilateral TKA * Staged bilateral TKA less than 6 months from indexed procedure * Patient is a current alcohol or drug abuser * Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.) * Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program * Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions * Patient with Neuropathic Arthropathy * Patient with any loss of musculature or neuromuscular disease that compromises the affected limb * Patients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limp Severity | 4-6 wks+3 days weeks post TKA | The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment | 4-6 wks+3 days weeks post TKA | Positive Percent Agreement (PPA) |
| Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment | 4-6 wks+3 days weeks post TKA | Negative Percent Agreement (NPA) |
| Knee Range of Motion | 4-6 wks+3 days weeks post TKA | ROM will be measured by a goniometer |
| Test-retest reliability of the Canary Medical Limping Model (CMLM) score | 4-6 wks+3 days weeks post TKA | Test-retest reliability of the CMLM score from day-to-day and week-to-week. (Specific days and weeks will be provided in the Statistical Analysis Plan.) |
| KOOS Jr | 4-6 wks+3 days weeks post TKA | Patient Reported outcome |
| Limping Self Evaluation | 4-6 wks+3 days weeks post TKA | Study participants will be asked the following question, During the past week, have you been limping when walking, because of your knee? The following answers will be allowed: * Rarely / never * Sometimes or just at first, after sitting for a long time * Often, not just at first * Most of the time * All of the time |
| Numeric Pain Rating Scale | 4-6 wks+3 days weeks post TKA | Subjective Pain Measurement |
Countries
United States
Contacts
Primary ContactDerek E. Coulter
Backup ContactNora York
Outcome results
None listed