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

NCT05223777 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-02-04

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

Traditional Handheld Mallet

The handheld mallet traditionally used in total hip arthroplasty.

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Todd A Kelley, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2023-09-30
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223777 on ClinicalTrials.gov