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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

634,336 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participants to join this experiment currently?

"As per the data on clinicaltrials.gov, this investigation is actively recruiting participants. It was initially published in September of 2021 and underwent an update as recently as January 24th 2022."

Answered by AI

To what extent has participation in this research study been successful?

"Affirmative. In accordance with the information found on clinicaltrials.gov, this medical study is currently looking for participants. It was initially posted on September 9th 2021 and modified most recently January 24th 2022; 50 patients are sought from 1 healthcare facility."

Answered by AI

Recent research and studies

Annals of Internal MedicineJournal

Putting Patients First by Reducing Administrative Tasks in Health Care: A Position Paper of the American College of Physicians

Erickson, Shari M., Brooke Rockwern, Michelle Koltov, Robert M. McLean, and for the Medical Practice and Quality Committee of the American College of Physicians. 2017. “Putting Patients First by Reducing Administrative Tasks in Health Care: A Position Paper of the American College of Physicians”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/m16-2697.

Mayo Clinic ProceedingsJournal

Relationship Between Clerical Burden and Characteristics of the Electronic Environment with Physician Burnout and Professional Satisfaction

Shanafelt, Tait D., Lotte N. Dyrbye, Christine Sinsky, Omar Hasan, Daniel Satele, Jeff Sloan, and Colin P. West. 2016. “Relationship Between Clerical Burden and Characteristics of the Electronic Environment with Physician Burnout and Professional Satisfaction”. Mayo Clinic Proceedings. Elsevier BV. doi:10.1016/j.mayocp.2016.05.007.

The Journal of ArthroplastyJournal

Modern Proximally Tapered Uncemented Stems Can Be Safely Used in Dorr Type C Femoral Bone

Dalury, David F., Todd C. Kelley, and Mary Jo Adams. 2012. “Modern Proximally Tapered Uncemented Stems Can Be Safely Used in Dorr Type C Femoral Bone”. The Journal of Arthroplasty. Elsevier BV. doi:10.1016/j.arth.2011.12.019.

Archives of Internal MedicineJournal