Clinical trial NCT05480813: Comparison Between Automated and Manual Component Impaction in Total Hip Arthroplasty
Official title: Comparison Between Automated and Manual Component Impaction in Total Hip Arthroplasty: Ergonomic and Efficiency Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty (THA)
Keywords: KINCISE™
Operational efficiency
Ergonomic impaction
Total Hip Arthroplasty (THA)
Lead sponsor: DEO NV
Sponsor class: INDUSTRY
Collaborators: name: BeScored Institute
First posted: 2022-07-29
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Hip surgeon

Exclusion Criteria:

* /

Primary outcomes:
measure: Cognitive fatigue - Mindfulness Inventory for Sport
timeFrame: 720 minutes
measure: Cognitive fatigue - Simon Task
timeFrame: 720 minutes
measure: Cognitive fatigue - Pattern-comparison task
timeFrame: 720 minutes
measure: Cognitive fatigue - Psychomotor task
timeFrame: 720 minutes
measure: Physical fatigue -
timeFrame: 720 minutes
measure: Physical fatigue - Shoulder endurance
timeFrame: 720 minutes
measure: Physical fatigue - Handgrip test
timeFrame: 720 minutes
measure: Physical fatigue - Isometric mid-thigh pull test
timeFrame: 720 minutes
measure: Stress - Salivary cortisol & alpha-amylase
timeFrame: 720 minutes
measure: Operational efficiency
timeFrame: 28 hours
measure: Ergonomic impaction
timeFrame: 28 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: DEO NV
name: Jeroen Dille
role: STUDY_DIRECTOR
References: