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

NCT05223777 | Unknown FDA Device

• 1 other identifier: OS20004 IRB 2020-0656
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• The Patient Health Questionnaire20 (PHQ-9)

  1 year

Study Arms (2)

KINCISE

ACTIVE COMPARATOR

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.

Device: KINCISE

Traditional Mallet

PLACEBO COMPARATOR

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

Device: Traditional Handheld Mallet

Interventions

KINCISE DEVICE

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.

KINCISE

Traditional Handheld Mallet DEVICE

The handheld mallet traditionally used in total hip arthroplasty.

Traditional Mallet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age less than 21.
• Incompatible smartphone device.
• History of neurological injury or pathology.
• Prior total joint athroplasty in the preceding year.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Univrsity of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Todd A Kelley, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly A Hasselfeld

CONTACT

5135581933; hasselky@uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: February 4, 2022
• Study Start: September 9, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)