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Procedure

KINCISE(TM) Surgical Automated System for Osteoarthritis

N/A

Waitlist Available

Research Sponsored by DePuy Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up operative

Awards & highlights

Study Summary

This trial will compare the time it takes to broach the femur for total hip arthroplasty using the Anterior Advantage approach with or without KINCISE.

Eligible Conditions

Osteoarthritis
Rheumatoid Arthritis
Arthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Femoral Broach Time

Secondary outcome measures

Change From 6-week Post-surgery in Forgotten Joint Score (FJS-12) at Week 24

Change From Pre-operative Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Weeks 6 and 24

Change From Pre-operative Baseline in European Quality of Life (EuroQol)-5 Dimension-5 Level (EQ-5D-5L) Heath State Index Total Score at Weeks 6 and 24

+16 more

Other outcome measures

Surgeon Heart Rate

Surgeon Surface Electromyography (EMG)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Anterior Approach with KINCISEExperimental Treatment1 Intervention

Anterior Approach THA using KINCISE(TM) Surgical Automated System

Group II: Anterior Approach without KINCISEActive Control1 Intervention

Anterior Approach THA with a mallet (without KINCISE)

Do I qualify?Apply below to find out

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Who is running the clinical trial?

DePuy OrthopaedicsLead Sponsor

79 Previous Clinical Trials

25,589 Total Patients Enrolled

44 Trials studying Osteoarthritis

10,663 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

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

Is this trial currently available to participants?

"As per clinicaltrials.gov, this specific trial is no longer recruiting participants; it debuted on January 28th 2020 and was last updated October 3rd 2022. Nevertheless, there are still 937 other studies that have open enrollment at the moment."

Answered by AI

In what locations is this scientific experiment accessible?

"This trial is accessible in 9 medical sites across the US. For example, The Orthopedic Specialty Center of Northern California (Roseville), Jordan-Young Institute (Virginia Beach), and North Texas Medical Research Institute (Dallas)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anterior Advantage With KINCISE

2020. "Anterior Advantage With KINCISE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04191733.