KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)

Study Purpose

There is a growing interest in the effects of mental health and wellness on orthopedic intervention outcomes, not only in terms of how advances in surgical procedures influence patient outcomes, but also with regard for physician physical and mental well-being. Although total hip arthroplasty (THA) is associated with favorable clinical outcomes as assessed by surgeon evaluation, radiographic analysis and implant longevity, unfavorable long-term pain and quality of life outcomes are consistently observed in upwards of 20% of patients receiving THAs. As such, the need to understand and address the determinants of positive and negative outcomes is of critical importance if the field hopes to continue to advance strategies to improve long-term outcomes for joint replacement. The overarching goal of this application is to assess the benefits of the KINCISE for patient recovery outcomes related to physical and mental well-being.

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.	Interventional
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Male and female participants over age 21 with a compatible smartphone (Apple iPhone 6s or newer running iOS 13 or higher) are eligible to participate.

- Participants must be community ambulatory.

Exclusion Criteria:

- Age less than 21.

- Incompatible smartphone device.

- History of neurological injury or pathology.

- Prior total joint athroplasty in the preceding year.

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.	NCT05223777
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.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Cincinnati
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Todd A Kelley, MD
Principal Investigator Affiliation	University of Cincinnati
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Hip

Additional Details

Participants. Participants (N= 50) will be recruited from the Department of Orthopaedic Surgery service at the University of Cincinnati Medical Center. The service refers approximately 240 patients for conventional THA annually, approximately 190 of which are performed by the PI. All participants will be paid for their participation. Clinical and Behavioral Assessments. Throughout the proposed work, we intend to examine patient recovery time, long-term pain outcomes, mood, and sleep habits. Assessments for pain, functionality, anxiety, and depression, will be administered electronically to each patient at study onset and conclusion using standardized psychological scales. Completion time for these psychological assessments is approximately 30 minutes. Phase 1: Preoperative Assessment (6 weeks prior to day of surgery). All patients will complete a study entrance exam consisting of clinical assessments of joint and pain functionality (HSS) and behavioral assessments of patient-reported general health (SF-36), joint pain and functionality (HOOS), anxiety (GAD-7), and depression (PHQ-9). Completion time for these assessments is approximately 30 minutes. Participants will also have the passive, automatic sensing app (Mae) installed on their smartphone to measure sleep habits, physical activity, social interaction, and mood. The app will collect passive sensing data and deliver the 3-minute weekly survey (as described above) throughout the entirety of the study. Phase 2: Surgical Intervention. Patients will undergo primary THAs through a direct anterior surgical approach using press fit implants. Anesthesia will be either general anesthesia or spinal anesthesia. Multimodal analgesia and rapid recovery techniques are used for all procedures. Twenty-five (25) of these procedures will be performed using the KINCISE and 25 will be performed using traditional handheld mallets. Patients will be pseudorandomly assigned to KINCISE or handheld mallet conditions to match for patient age, sex, and preoperative functionality and pain scores. Assignments to treatment conditions will be counterbalanced to account for the number of TJAs performed each day by the surgeon. All surgeries will be recorded using a high definition digital camera compatible for use in OS#, UC IRB 2020-XXXXVersion 1.0 pg. 5 surgical suites. The camera will be positioned so as not to record the patient's face. Video and audio recording will be used to calculate broach time, total length of each procedure, and mallet strikes. Phase 3: Postoperative Longitudinal Study of Sleep, Mood, and Pain. Patients will be followed longitudinally for one year after surgery. During this phase, sleep habits, physical activity, social interaction, and mood data will continue to be collected and weekly assessments of mood, functionality, and pain will continue to be administered using the Mae smartphone app. Post-operative clinical assessments (HHS) and patient reports of joint pain and functionality (HOOS) will be administered and collected at six weeks, three months, and one year for all patients. At the one-year time point, patients will additionally complete full versions of the SF-36, the PHQ-9 depression scale, and the GAD-7 anxiety scale. Of interest is whether KINCISE-guided procedures result in more favorable recovery times and pain outcomes and whether such changes are accompanied by improved sleep quality and reduced anxiety and depression. Because Mae employs continuous data collection through passive sensing and weekly surveys, the research project offers a unique opportunity to study the duration of improvements in functionality and pain reduction at a level of granularity that cannot be accomplished by periodic office follow-ups alone (e.g., when do patients reach/surpass their preoperative walking speed?).

Arms & Interventions

Arms

Active Comparator: KINCISE

The KINCISE™ Surgical Automated System (KINCISE) (DePuy Synthes Products, Inc, Warsaw, IN) was developed to replace the handheld mallet traditionally used in total hip arthroplasty (THA). The device is an FDA-approved medical instrument. As such, the focus of the study does not relate to the safety and efficacy of the device, which has already been established. Instead, the current IRB proposal investigates whether there are long-term benefits to patient outcomes that differ between KINCISE-guided versus mallet THA.

Placebo Comparator: Traditional Mallet

A traditional mallet will be used during surgery in this group.

Interventions

Device: - KINCISE

Device: - Traditional Handheld Mallet

The handheld mallet traditionally used in total hip arthroplasty.

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.

Univrsity of Cincinnati Medical Center, Cincinnati, Ohio

Status

Recruiting

Address

Univrsity of Cincinnati Medical Center

Cincinnati, Ohio, 45267

Site Contact

Kim Hasselfeld, MS

[email protected]

513-777-6213

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