Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PersonaIQ | Patients indicated for a PersonaIQ total knee arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Limping Evalution | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Limp Severity | 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). | 4-6 wks+3 days weeks post TKA |
| Measure | Description | Time Frame |
|---|---|---|
| Test-retest reliability of the Canary Medical Limping Model (CMLM) score | 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.) | 4-6 wks+3 days weeks post TKA |
| Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment |
Not provided
Inclusion Criteria:
• Patient must be 18 years of age or older
Exclusion Criteria:
• Simultaneous bilateral TKA
Not provided
Not provided
Not provided
Patients indicated for a commercially available PIQ TKA implant who meet the inclusion and exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derek E. Coulter | Contact | 18066816979 | dcoulter@canarymedical.com | |
| Nora York | Contact | nyork@canarymedical.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Orthopaedic & Neurosurgical Associates | Recruiting | Spartanburg | South Carolina | 29303 | United States |
Not provided
Not provided
Not provided
Not provided
|
|
Positive Percent Agreement (PPA) |
| 4-6 wks+3 days weeks post TKA |
| Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment | Negative Percent Agreement (NPA) | 4-6 wks+3 days weeks post TKA |
| Knee Range of Motion | ROM will be measured by a goniometer | 4-6 wks+3 days weeks post TKA |
| Numeric Pain Rating Scale | Subjective Pain Measurement | 4-6 wks+3 days weeks post TKA |
| KOOS Jr | Patient Reported outcome | 4-6 wks+3 days weeks post TKA |
| Limping Self Evaluation | 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:
| 4-6 wks+3 days weeks post TKA |