MedDataX Logo

Comparison Between Automated and Manual Component Impaction in Total Hip Arthroplasty

NCT ID: NCT05480813

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2022-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will investigate and evaluate the ergonomic impaction and the operational efficiency of the KINCISE™ impaction system in comparison with the manual impaction of a handheld traditional mallet in total hip arthroplasty (THA) procedures.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The automated impaction technology of Depuy Sythes (J\&J, Warschau), i.e. KINCISE™, can help surgeons impacting the femur in THA surgeries with constant and consistent energy. Furthermore, the bone preparation, implant positioning and implant assembly automate. Next to that, the KINCISE™ is developed to eliminate mallet impaction methods and thus can reduce the physical fatigue of the surgeon during THA procedures, leading to more reproducible and accurate femur manipulation even during the last procedure of the OR day. Two main research questions will be investigated: "Does the KINCISE™ automated impaction lead to a significant reduction in mental and physical fatigue in comparison with mallet impaction?" and "Does the KINCISE™ automated impaction lead to a reduction in OR time?".

Measurements will be executed during 4 OR days. During each OR day exclusively Kincise impaction (N=2) or handheld traditional mallet impaction (N=2) will be performed. The impaction technique will be randomised and the OR setup will be equal in both situations. The one participant in the study is an orthopaedic hip surgeon. He will execute all the THA procedures and undergo all the physical and cognitive tests. The entire study will be assessed by 2 parties of experienced assessors who are not involved in the surgical procedures: BeScored Institute and DEO.

Each OR day, 2 evaluation sessions and 1 mid break session will be held, led by BeScored Institute: in the morning from 06:50am till 08am, during the afternoon from 03:30pm till 04:40pm and during lunch breaks from 11:30am till 12:05pm. Before each morning evaluation session a cognitive task test of 5 minutes will be executed to get familiar with the cognitive tasks of the evaluation sessions. During each evaluation session the following tests will be executed in the same order: psychometric assessments (7 minutes, consisting of 'mindfulness inventory for sport' questionnaire, perfection for stress scale and observed physical fatigue), energy evaluation and stress levels (5 minutes, consisting of heart beat variability measurements, saliva cortisol levels and saliva alfa-amylase levels), cognitive tasks (30 minutes, consisting of Simon test, pattern-comparison test and psychomotor test) and physical tests (20 minutes, consisting of handgrip test, shoulder endurance, planking and isometric mid-thigh pull performance). During the mid break session only the psychometric assessments and cognitive tasks will be executed.

During the THA procedures itself, DEO will evaluate other ergonomics and operational efficiency using the validated DEO Data Collection Platform including datapoints specific to the use of automated and manual impaction, and RULA and REBA methods.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Hip Arthroplasty (THA)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

KINCISE™ Operational efficiency Ergonomic impaction Total Hip Arthroplasty (THA)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

The one participant of the study is an orthopaedic surgeon. He will execute 48 THA procedures during 4 study days. 24 THA procedures will be executed using the automated KINCISE™ impaction system and 24 THA procedures will be executed using a traditional handheld mallet. He will undergo physical and cognitive tests before the OR day, during lunch breaks and after the OR day. Next to that, operational efficiency and ergonomic impaction will be analysed.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prof. Dr. K. Corten

The one participant of the study is an orthopaedic surgeon. He will execute 48 THA procedures during 4 study days. 24 THA procedures will be executed using the automated KINCISE™ impaction system and 24 THA procedures will be executed using a standard mallet. He will undergo physical and cognitive test before and after the OR day and during lunch breaks. Next to that, operational efficiency and ergonomic impaction will be analysed

Group Type OTHER

Automated KINCISE™ impaction system versus handheld traditional mallet

Intervention Type DEVICE

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.

Efficiency and ergonomics analysis and physical assessments

Intervention Type OTHER

Operational efficiency, ergonomic impaction, cognitive/physical/stress level evaluations,

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Automated KINCISE™ impaction system versus handheld traditional mallet

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.

Intervention Type DEVICE

Efficiency and ergonomics analysis and physical assessments

Operational efficiency, ergonomic impaction, cognitive/physical/stress level evaluations,

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Hip surgeon

Exclusion Criteria

* /
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BeScored Institute

UNKNOWN

Sponsor Role collaborator

DEO NV

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeroen Dille

Role: STUDY_DIRECTOR

DEO NV

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KINCISE

Identifier Type: -

Identifier Source: org_study_id