Recruiting

KINCISE™

Sponsor:

University of Cincinnati

Code:

NCT05223777

Conditions

Osteoarthritis, Hip

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

KINCISE

Traditional Handheld Mallet

Study Details

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

Study ID

NCT05223777

Start date

Sep 9, 2021

Status verified date

Jan, 2022

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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.

Primary outcome measure

  • The Short Form (36) Health Survey [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kimberly A Hasselfeld

5135581933hasselky@uc.edu

Locations

Univrsity of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Kim Hasselfeld, MS

513-777-6213hasselky@uc.edu

Henry Sagi, MD

5137776213

More Information

Sponsor

University of Cincinnati

Last update posted

Feb 4, 2022

Last verified

Jan, 2022

Keywords

  • total hip arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2022-02-04.