Assessing walking ability after knee surgery using a new device
A Multicenter, Single- Arm Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
Canary Medical · NCT05693818
This study is testing a new device to see how well it can help doctors check how much a person's walking ability improves after knee surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Canary Medical (industry) |
| Locations | 1 site (Spartanburg, South Carolina) |
| Trial ID | NCT05693818 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the accuracy of a limp detection model following total knee arthroplasty using the Canary canturioTM te tibial extension. Patients will be assessed for limp severity by healthcare providers at a 4-6 week follow-up visit, utilizing a 3-point Likert scale to categorize the severity of their limp. The study will include patients who are indicated for a commercially available PersonaIQ TKA implant and are willing to participate in the follow-up protocol. The goal is to improve the assessment of post-surgical recovery and walking ability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for a total knee arthroplasty with a PersonaIQ implant.
Not a fit: Patients undergoing simultaneous bilateral total knee arthroplasties or those with significant psychiatric or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of limp assessments, leading to better post-operative care and recovery strategies for knee surgery patients.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel assessment method.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Spartanburg, South Carolina
- Carolina Orthopaedic & Neurosurgical Associates — Spartanburg, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Derek E. Coulter
- Email: dcoulter@canarymedical.com
- Phone: 18066816979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arthritis Knee, total knee arthroplasty, PersonaIQ