ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

U1111-1253-7503

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hip Osteoarthritis

Hip Rheumatoid Arthritis

Osteonecrosis of the Femoral Head

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Surgery

Surgical techniques

Musculoskeletal

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]

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]

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]

following postoperative review (by ~6 weeks postop)

Primary outcome [2]

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]

following postoperative review (by ~6 weeks postop)

Primary outcome [3]

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]

following postoperative review (by ~6 weeks postop)

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4221 - Palm Beach

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Naviswiss AG

Address [1]

Stahlrain 2, 5200 Brugg

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

EBM Analytics

Address [1]

119 Willoughby Road,
Crows Nest NSW 2065

Country [1]

Australia

Other collaborator category [2]

Commercial sector/Industry

Name [2]

Active Surgical Pty Ltd

Address [2]

138 Milson Rd,
Cremorne Point NSW 2090

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ramsay Health Care QLD Human Research Ethics Committee

Ethics committee address [1]

Newdegate St, Greenslopes QLD 4120

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/05/2020

Approval date [1]

10/08/2020

Ethics approval number [1]

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

Dr Dr David Liu

Address

Gold Coast Centre for Bone & Joint Surgery
14 Sixth Avenue
Palm Beach, QLD, 4221

Country

Australia

Phone

+61755980205

Fax

drdliu1@bigpond.com

Contact person for public queries

Name

Agnes Mallard

Address

Gold Coast Centre for Bone & Joint Surgery
14 Sixth Avenue
Palm Beach, QLD, 4221

Country

Australia

Phone

+61755980205

Fax

agnes@gccbjs.com.au

Contact person for scientific queries

Name

Corey Scholes

Address

EBM Analytics
119 Willoughby Road,
Crows Nest NSW 2065

Country

Australia

Phone

+61299563800

Fax

cscholes@ebma.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
8253	Ethical approval			cscholes@ebma.com.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Imageless 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.	2024	https://dx.doi.org/10.1186/s42836-023-00224-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically