KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)
NCT ID: NCT05223777
Last Updated: 2022-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-09-09
2024-09-30
Brief Summary
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Detailed Description
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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?).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Traditional Mallet
A traditional mallet will be used during surgery in this group.
Traditional Handheld Mallet
The handheld mallet traditionally used in total hip arthroplasty.
Interventions
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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.
Traditional Handheld Mallet
The handheld mallet traditionally used in total hip arthroplasty.
Eligibility Criteria
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Inclusion Criteria
* Participants must be community ambulatory
Exclusion Criteria
* Incompatible smartphone device.
* History of neurological injury or pathology.
* Prior total joint athroplasty in the preceding year.
21 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Todd Kelley
Assistant Professor
Principal Investigators
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Todd A Kelley, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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Univrsity of Cincinnati Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Henry Sagi, MD
Role: backup
References
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Other Identifiers
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OS20004 IRB 2020-0656
Identifier Type: -
Identifier Source: org_study_id
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