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).
Study Type
OBSERVATIONAL
Enrollment
88
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.
Carolina Orthopaedic & Neurosurgical Associates
Spartanburg, South Carolina, United States
RECRUITINGLimp 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).
Time frame: 4-6 wks+3 days weeks post TKA
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.)
Time frame: 4-6 wks+3 days weeks post TKA
Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment
Positive Percent Agreement (PPA)
Time frame: 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)
Time frame: 4-6 wks+3 days weeks post TKA
Knee Range of Motion
ROM will be measured by a goniometer
Time frame: 4-6 wks+3 days weeks post TKA
Numeric Pain Rating Scale
Subjective Pain Measurement
Time frame: 4-6 wks+3 days weeks post TKA
KOOS Jr
Patient Reported outcome
Time frame: 4-6 wks+3 days weeks post TKA
Limping Self Evaluation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 4-6 wks+3 days weeks post TKA