None listed
Conditions
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.
Interventions
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 aft
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.
Sponsors
David Liu
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients eligible for primary elective THA using an anterolateral approach in the lateral decubitus position
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
Outcome results
None listed