Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05693818
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Canary Medical
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthritis Knee

Additional Details

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).

Arms & Interventions

Arms

: PersonaIQ

Patients indicated for a PersonaIQ total knee arthroplasty

Interventions

Other: - Clinical 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Spartanburg, South Carolina

Status

Recruiting

Address

Carolina Orthopaedic & Neurosurgical Associates

Spartanburg, South Carolina, 29303

Site Contact

Daniel Gerscovich, MD

[email protected]

864-582-6396

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