Accuracy of a new navigation system for total hip replacement

Concurrent validity of intraoperative imageless navigation (Naviswiss™) for component positioning accuracy in primary total hip arthroplasty: A prospective observational cohort study in a single-surgeon practice with three-dimensional reconstruction of computed tomography as gold standard

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12620000089932

Enrollment

Registered

2020-02-03

Start date

2020-02-24

Completion date

2021-08-22

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Optimal outcomes in total hip arthroplasty are dependent on appropriate component placement, with technological advances providing a platform for guiding component placement to reduce the risk of malpositioned components during surgery. This study will validate the accuracy of the data captured using a handheld imageless navigation system (for total hip arthroplasty) against pre/postoperative CT scans. Patients are to be recruited and data captured as part of the existing approved protocol for John Ireland's patient registry [ACTRN12618000317291].

Interventions

Total Hip Arthroplasty with a cemented standard stem and cementless acetabular cup, using an anterolateral approach. Guidance for component positioning will be provided intraoperatively using the Naviswiss image-free navigation system, as is standard for this surgeon. 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. As per the surgeon's standard practice, the same patients will undergo a preoperative, and a follow-up CT scan at 6-8 weeks following surgery (therefore the total observation duration will be 6-8 weeks). These scans will be used to provide positioning measurements which will be compared to those obtained in surgery with the navigation device.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients eligible for primary elective THA using an anterolateral approach in the supine position

Exclusion criteria

Patients who have declined or revoked consent for use of clinical data for research, or unable to provide informed consent. Patients requiring/electing to have simultaneous bilateral procedures Patients with severe contralateral hip deformity or dysplasia Patients eligible for insertion of a short-stem component Patients with previous ipsilateral hip arthroplasty eligible for revision

Outcome results