Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000873921
Ethics application status
Approved
Date submitted
1/07/2020
Date registered
2/09/2020
Date last updated
9/01/2023
Date data sharing statement initially provided
2/09/2020
Date results information initially provided
9/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Accuracy of the Naviswiss™ navigation system for total hip replacement
Scientific title
Validity of intraoperative imageless navigation (Naviswiss™) for component positioning accuracy in primary total hip arthroplasty via a lateral position: A prospective observational cohort study in a single-surgeon practice
Secondary ID [1] 301548 0
None
Universal Trial Number (UTN)
U1111-1253-7503
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis 317911 0
Hip Rheumatoid Arthritis 317912 0
Osteonecrosis of the Femoral Head 318495 0
Condition category
Condition code
Musculoskeletal 315950 315950 0 0
Osteoarthritis
Surgery 315951 315951 0 0
Surgical techniques
Musculoskeletal 315952 315952 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Total hip arthroplasty (THA) using an anterolateral surgical approach in the lateral decubitus position. Guidance for component positioning will be provided intraoperatively using the Naviswiss™ image-free navigation system, which is currently used as standard for the primary investigator. The Naviswiss™ system uses single-use tags which are pinned to relevant anatomical regions, and a handheld camera to collect measurements relevant to positioning of the hip implants both before, during and after component insertion.

Patients will undergo a preoperative and follow-up CT scan (by 6 weeks following surgery) as per the study protocol. These scans will be retrieved from the picture archiving and communication system (PACS) after the routine postoperative follow up with the surgeon. The position of the hip components will be measured using the retrieved CT scans and compared to those obtained intra-operatively with the navigation device.

The current study will provide supplementary information regarding the accuracy of the Naviswiss navigation system to a separate study, ACTRN12620000089932, which aims to assess the accuracy of the Naviswiss device in a separate cohort of participants, that will undergo the total hip arthroplasty surgery via a different position.
Intervention code [1] 317851 0
Not applicable
Comparator / control treatment
Pre and postoperative computed tomography, with measurements compared to those obtained intra-operatively with the navigation device from the same patients.
Control group
Active

Outcomes
Primary outcome [1] 324157 0
Validity of Naviswiss™ measurements of acetabular cup inclination (the angle between the acetabular and longitudinal axes when projected onto the coronal plane).
Assessed by comparing standard error of measurement between intraoperative Naviswiss™ and CT-based measurements of inclination.
Timepoint [1] 324157 0
following postoperative review (by ~6 weeks postop)
Primary outcome [2] 324158 0
Validity of Naviswiss™ measurements of acetabular cup anteversion (the angle between the acetabular axis and coronal plane).
Assessed by comparing standard error of measurement between intraoperative Naviswiss™ and CT-based measurements of anteversion.
Timepoint [2] 324158 0
following postoperative review (by ~6 weeks postop)
Primary outcome [3] 324159 0
Validity of Naviswiss™ measurements of change in femoral offset (pre-post surgery).
Assessed by comparing standard error of measurement between intraoperative Naviswiss™ and CT-based measurements of femoral offset.
Timepoint [3] 324159 0
following postoperative review (by ~6 weeks postop)
Secondary outcome [1] 383885 0
Validity of Naviswiss™ measurements of change in leg length pre-post implant.
Assessed by comparing standard error of measurement between intraoperative Naviswiss™ and CT-based measurements of leg length.
Timepoint [1] 383885 0
following postoperative review (by ~6 weeks postop)

Eligibility
Key inclusion criteria
Patients eligible for primary elective THA using an anterolateral approach in the lateral decubitus position
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have declined or revoked consent for use of clinical data for research, or are unable to provide informed consent.

Patients eligible for insertion of a short-stem component

Patients requiring/electing to have simultaneous bilateral procedures

Patients with severe contralateral hip deformity or dysplasia

Patients with previous ipsilateral hip arthroplasty eligible for revision

Patients who are lost to follow-up

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The minimum sample size required for the study was established to provide adequate power to detect a 2.5° absolute mean difference between intraoperative navigation results and postoperative CT measurements using a paired t-test design (each patient acts as their own control), with an assumed between-patient standard deviation of 5°. The standard deviation was estimated from an initial pilot study with 15 cases during the learning curve (2.4° for inclination and 2° for version) with an additional margin of error added. Power (beta) was selected at 0.8 and a of 0.05 with an estimated sample size of 35 cases.

The minimum sample size necessary for the multivariable regression analysis (N = 30) with patient age at surgery, sex and body mass index selected as the model predictors was estimated from a model R2 of 0.3, three predictors and the same B (beta) and A (alpha).

The data analysis plan will include reporting the characteristics of the study cohort in a STROBE (Strengthening the Reporting of Observational studies in Epidemiology) diagram (Vandenbroucke et al., 2007). The accuracy of the NaviswissTM system will be validated by calculating the differences between intraoperative and postoperative measurements of the primary outcome variables and determining the limits of agreement. Mixed effects linear regression will be used to compare intraoperative data and postoperative CT measurements of the primary outcomes. Residual analysis from the model will be used to determine the standard error of measurement of the navigation system relative to CT measurements..

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/09/2020
Actual
9/11/2020
Date of last participant enrolment
Anticipated
1/05/2022
Actual
28/03/2022
Date of last data collection
Anticipated
1/10/2022
Actual
15/06/2022
Sample size
Target
34
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 30685 0
4221 - Palm Beach

Funding & Sponsors
Funding source category [1] 305985 0
Commercial sector/Industry
Name [1] 305985 0
Naviswiss AG
Country [1] 305985 0
Switzerland
Primary sponsor type
Individual
Name
David Liu
Address
Gold Coast Centre for Bone & Joint Surgery
14 Sixth Avenue
Palm Beach, QLD, 4221
Country
Australia
Secondary sponsor category [1] 306581 0
None
Name [1] 306581 0
Address [1] 306581 0
Country [1] 306581 0
Other collaborator category [1] 281369 0
Commercial sector/Industry
Name [1] 281369 0
EBM Analytics
Address [1] 281369 0
119 Willoughby Road,
Crows Nest NSW 2065
Country [1] 281369 0
Australia
Other collaborator category [2] 281370 0
Commercial sector/Industry
Name [2] 281370 0
Active Surgical Pty Ltd
Address [2] 281370 0
138 Milson Rd,
Cremorne Point NSW 2090
Country [2] 281370 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306224 0
Ramsay Health Care QLD Human Research Ethics Committee
Ethics committee address [1] 306224 0
Newdegate St, Greenslopes QLD 4120
Ethics committee country [1] 306224 0
Australia
Date submitted for ethics approval [1] 306224 0
27/05/2020
Approval date [1] 306224 0
10/08/2020
Ethics approval number [1] 306224 0
HREC Reference number: 20/08

Summary
Brief summary
Optimal outcomes in total hip arthroplasty (THA) require accurate implant positioning, which is improved with the use of navigation systems. This study aims to assess the validity of intraoperative data captured using a new handheld imageless navigation device with limited clinical evidence.

Data will be collected in a prospective observational cohort study, and informed consent will be required from eligible participants. Patients will undergo standard of care consultation for diagnosis and treatment, including the collection of demographic and surgical data. Patients will be referred to pre and postoperative CT imaging as per the study protocol.

An accuracy analysis will compare intraoperative surgical positioning data from the navigation device to measurements from preoperative and follow-up CT scans.

The primary outcome is the agreement between intraoperative data captured by the navigation system, compared to postoperative measurements performed on CTs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103154 0
Dr Dr David Liu
Address 103154 0
Gold Coast Centre for Bone & Joint Surgery
14 Sixth Avenue
Palm Beach, QLD, 4221
Country 103154 0
Australia
Phone 103154 0
+61755980205
Fax 103154 0
Email 103154 0
[email protected]
Contact person for public queries
Name 103155 0
Ms Agnes Mallard
Address 103155 0
Gold Coast Centre for Bone & Joint Surgery
14 Sixth Avenue
Palm Beach, QLD, 4221
Country 103155 0
Australia
Phone 103155 0
+61755980205
Fax 103155 0
Email 103155 0
[email protected]
Contact person for scientific queries
Name 103156 0
Dr Corey Scholes
Address 103156 0
EBM Analytics
119 Willoughby Road,
Crows Nest NSW 2065
Country 103156 0
Australia
Phone 103156 0
+61299563800
Fax 103156 0
Email 103156 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data obtained during this study contains both identifiable patient data and commercially sensitive information, and is thus not suitable for sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8253Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImageless navigation system (Naviswiss) provides accurate component position in total hip arthroplasty with lateral decubitus position for end-stage hip osteoarthritis: a prospective cohort study with CT-validation.2024https://dx.doi.org/10.1186/s42836-023-00224-0
N.B. These documents automatically identified may not have been verified by the study sponsor.