Comparison Between Automated and Manual Component Impaction in Total Hip Arthroplasty

NCT05480813 | Completed

• 1 other identifier: KINCISE
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Hip Arthroplasty (THA)

Keywords

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

Outcome Measures

Primary Outcomes (11)

• Cognitive fatigue - Mindfulness Inventory for Sport

  The surgeon's ability to remain mindful during the working day will be assessed via the Mindfulness Inventory for Sport, adapted for the purpose of this study. Specifically, this questionnaire involves 15 items and 3 dimensions of mindfulness: awareness, non-judgmentally, refocusing. In addition, a modified version of the Perception for Stress Scale will be used before and after. Perceived physical fatigue has also been assessed at rest using a 10-cm visual analogic scale ranging from "Not fatigued at all" to "Very fatigued". Finally, after each physical testing, the participant will be asked to provide a verbal rating of perceived exertion (RPE) using a visual Borg (6-20) scale\[26\]. RPE was defined as the "perceived difficulty to exert the physical effort before exhaustion".

  720 minutes

• Cognitive fatigue - Simon Task

  The Simon task is a selective inhibition task in which the participant is required to respond as quickly and accurately as possible to the color of a stimulus displayed on a screen regardless its spatial location. Then, depending on its left or right location, the user may be required to withdraw an automatic impulse to be able to answer according to the color of the stimulus. The participant will be asked to respond by pressing the appropriate left or right buttons according to the color of a circle delivered either to the left or to the right of the white gaze-fixation cross. The task includes two equiprobable trial types: the congruent trials during which the spatial location of the stimulus corresponded to the task-relevant aspect of the stimulus, and the incongruent trials in which the spatial location of the stimulus corresponded to the opposite spatial location of the response.

  720 minutes

• Cognitive fatigue - Pattern-comparison task

  A pattern-comparison task will also be carried out to assess the surgeon's ability to visually identify anomalies, equipment failures, compliance checks, etc. throughout a surgery. Specifically, in order to test the surgeon's ability to quickly determine the compatibility (similarity) and incompatibility (dissimilarity) of stimuli, a visual comparison task will be performed. The aim will be to respond via the computer keyboard to the convergent dimension of 2 images displayed on the screen for 30 trials, and then to the non-convergent dimension for another 30 trials, in a time lapse of 1.5 sec per trial.

  720 minutes

• Cognitive fatigue - Psychomotor task

  The effectiveness of the and surgeon's motor control will be assessed to consider whether careful manual interventions could potentially be affected by both surgical conditions (Kincise automated impaction vs handheld impaction). A psychomotor task will therefore be formed with the instruction to follow, via a computer mouse, the predictable movement of a light spot on the screen. One minute of evaluation will be carried out, with the time of contact with the light target and the average distance to this target as variables of interest.

  720 minutes

• Physical fatigue -

  A plank to fatigue test (PFT) will be used to assess lumbar muscle fatigue. Between experimental sessions, the same distance between the 2 feet, between the 2 elbows and between the hip and the floor, will be required for each participant. The distance between the hip and the floor shall serve as the measure of exhaustion. Exhaustion is declared when the distance between the participant's hip and the floor is reduced by more than 2 cm for more than 5 sec.

  720 minutes

• Physical fatigue - Shoulder endurance

  Shoulder endurance and deltoideus anterior muscle fatigue will be assessed via light weightlifting. In particular, the participant will be required to maintain a 3 kg weight in front of him, with the arms stretched out (perpendicular to the trunk, 90° adduction) and during 3 periods of 10 sec interspaced with 10-sec resting periods.

  720 minutes

• Physical fatigue - Handgrip test

  A handgrip test will be carried out using a hand dynamometer (microFET® Digital HandGRIP Dynamometer, USA). This shall enable us to assess the strength decline of the flexor's muscles of the participant's dominant hand. Ten repeated maximal voluntary contractions shall be performed in 20 sec (i.e., 1 contraction every 2 sec).

  720 minutes

• Physical fatigue - Isometric mid-thigh pull test

  an Isometric Mid-Thigh Pull Performance (IMTPP) will be used as a measure of thighs strength of endurance. The posture of this exercise is characterized by the two right angles formed by the body, one at the hips and one at the knees. The participant will also be required to keep their arms stretched out in front of them until exhaustion to avoid compensation movements.

  720 minutes

• Stress - Salivary cortisol & alpha-amylase

  We will observe the variations of both salivary cortisol and alpha-amylase in this study at different timepoints. On the morning of each experimental day and at the end of the surgery, the surgeon will provide a 4-mL saliva sample via passive drool. The samples will be obtained in a fasted-state at 5:00 AM and at 4:40 PM and will be promptly frozen at -80°C

  720 minutes

• Operational efficiency

  Efficiency will be assessed using OR time, by comparing the OR days and procedures where the KINCISE tool or the mallet is used. A granular analysis from the timestamps will be conducted using standard descriptive statistics. Additionally, the impaction process will be further analyzed, broken down into parts.

  28 hours

• Ergonomic impaction

  Measurement of weight of Kincise and mallet, audio of impaction (Kincise vs mallet) and the surgeon's posture assessment using RULA and REBA method will be combined to report ergonomic impaction on the surgeon by DEO

  28 hours

Study Arms (1)

Prof. Dr. K. Corten

OTHER

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

Device: Automated KINCISE™ impaction system versus handheld traditional mallet; Other: Efficiency and ergonomics analysis and physical assessments

Interventions

Automated KINCISE™ impaction system versus handheld traditional mallet 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.

Prof. Dr. K. Corten

Efficiency and ergonomics analysis and physical assessments OTHER

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

Prof. Dr. K. Corten

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hip surgeon

Sponsors & Collaborators

• DEO NV: lead
• BeScored Institute: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Interventions

Efficiency

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Jeroen Dille

  DEO NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 29, 2022
• Study Start: July 14, 2022
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)