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Procedure

KINCISE for Osteoarthritis

N/A
Recruiting
Led By Todd A Kelley, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be community ambulatory
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is looking at the effects of mental health and wellness on patients who have had hip replacement surgery, in terms of how well they recover physically and mentally.

Who is the study for?
This trial is for men and women over 21 years old who can walk on their own and have a compatible smartphone (iPhone 6s or newer with iOS 13+). It's not for those under 21, anyone who had joint replacement in the last year, without the right phone, or with a history of neurological issues.Check my eligibility
What is being tested?
The study is comparing traditional tools like handheld mallets to an automated system called KINCISE in hip replacement surgery. The goal is to see if KINCISE improves patient recovery outcomes related to physical and mental well-being after surgery.See study design
What are the potential side effects?
While specific side effects are not listed for using KINCISE, typical risks associated with hip replacement surgeries may include pain at the site, infection risk, blood clots, or complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can walk around in my community without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Short Form (36) Health Survey
Secondary outcome measures
The Patient Health Questionnaire20 (PHQ-9)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: KINCISEActive Control1 Intervention
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.
Group II: Traditional MalletPlacebo Group1 Intervention
A traditional mallet will be used during surgery in this group.

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
430 Previous Clinical Trials
634,441 Total Patients Enrolled
Todd A Kelley, MDPrincipal InvestigatorUniversity of Cincinnati

Media Library

KINCISE (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05223777 — N/A
Osteoarthritis Research Study Groups: KINCISE, Traditional Mallet
Osteoarthritis Clinical Trial 2023: KINCISE Highlights & Side Effects. Trial Name: NCT05223777 — N/A
KINCISE (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05223777 — N/A
~14 spots leftby Jun 2025
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