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

Primary Purpose

Osteoarthritis, Hip

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KINCISE
Traditional Handheld Mallet
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring total hip arthroplasty

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univrsity of Cincinnati Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

KINCISE

Traditional Mallet

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The Short Form (36) Health Survey
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

Secondary Outcome Measures

The Patient Health Questionnaire20 (PHQ-9)
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

Full Information

First Posted
July 1, 2021
Last Updated
January 24, 2022
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT05223777
Brief Title
KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)
Official Title
KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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?).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
total hip arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will undergo primary total hip athroplasties 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KINCISE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Traditional Mallet
Arm Type
Placebo Comparator
Arm Description
A traditional mallet will be used during surgery in this group.
Intervention Type
Device
Intervention Name(s)
KINCISE
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional Handheld Mallet
Intervention Description
The handheld mallet traditionally used in total hip arthroplasty.
Primary Outcome Measure Information:
Title
The Short Form (36) Health Survey
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The Patient Health Questionnaire20 (PHQ-9)
Description
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly A Hasselfeld
Phone
5135581933
Email
hasselky@uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd A Kelley, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univrsity of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Hasselfeld, MS
Phone
513-777-6213
Email
hasselky@uc.edu
First Name & Middle Initial & Last Name & Degree
Henry Sagi, MD
Phone
5137776213

12. IPD Sharing Statement

Plan to Share IPD
No
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KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)

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