Clinical trial NCT05159206: CT-based 3D Planning, Computer Navigation and Subsequent Migration Analysis in Total Hip Arthroplasty
Official title: Evaluation of a Novel CT-based 3D Planning, Computer Navigation and Subsequent Migration Analysis in Total Hip Arthroplasty: A Single Arm Study With 2 Years Follow-up
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Hip Osteoarthritis
Total Hip Arthroplasty
CT templating
CT migration analysis
CT navigation
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group of patients undergoing total hip arthroplasty with a new technique of preoperative templating, per-operative navigation and postoperative migration analysis.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate a new technique that optimizes the prosthesis position for patients who undergo total hip arthroplasty surgery. Today, most surgeons take a regular X-ray (2D) to plan the surgery. In this study, patients will do a computed tomography (CT) before surgery, and with the use of the new system, the investigators will be able to make a more accurate plan when it comes to prosthetic placement and leg length adjustment in 3D. The software uses artificial intelligence (AI) to generate the information required for clinical conclusions automatically, and it enables surgeons to adapt to each unique case and anticipate situations during surgery. The system also helps the surgeon during operation with a navigation tool to place the implant in the pre-operatively planned position. It guides surgeons in real-time to place the implants accurately. To see whether the plan and navigation were correct, the investigators will do a new computed tomography after surgery to look at the achieved result.

In addition to planning and navigation, the same system can be used to measure the migration of the prosthesis in relation to the bone over time using AI by comparing multiple scans. The investigators aim to follow all patients for 2 years (total of 4 CT scans after surgery) with the intention to be able to foresee implant loosening.

Detailed description: The aim of this study is to evaluate a new system for CT-based 3D planning, navigation and subsequent postoperative migration analysis in patients with total hip arthroplasty (THA). Patients (age 40-75 years) with osteoarthritis, eligible for surgery, are asked to participate, and the investigators plan to follow all patients for 2 years after surgery.

In THA surgery, the goal is to recreate the natural motion-center of the hip, adjust for possible leg length differences and to optimize prosthetic placement to reduce the risk of future dislocation or loosening. Today, usually a plain X-ray is taken before the operation to plan size and position. This has its limitations since the surgeon can not assess the 3D position on a 2D image. In this study, the investigators are using a new system for planning in 3D, based on a low-dose CT scan and with the help of AI. Moreover, the surgeon get real-time information of the prosthetic position during surgery (called navigation), after matching the physical patient to a virtual patient. The hypothesis is that prosthetic placement and patient satisfaction will improve with 3D planning and navigation, resulting in a more anatomical restoration, and that postoperative complications, such as dislocation and ultimately loosening will reduce.

Entering this study entails taking a CT scan before surgery (instead of a plain X-ray), and for validation, a postoperative CT scan. This enables the investigators to find out whether the planning and navigation are confirmed by the postoperative position. In addition to planning and navigation, the investigators wish to implement a way of measuring prosthetic migration after surgery. Today, this is done by implanting small metal (tantalum) markers in the bone during surgery, and then measuring the distance between prosthesis and markers over time in a special software on multiple X-rays (This method is called RSA, Radiostereometric Analysis). However, few hospitals have the expertise or equipment to do these analyses and it is a somewhat laborious process. This study will evaluate a new tool for making equivalent migration analysis, based on CT scans. By matching the postoperative CT image to subsequent CT scans at 3 months, 1 and 2 years after surgery, the investigators can see how much the prosthesis has moved in relation to the bone and hopefully being able to foresee future loosening. The hypotheses is that CT migration analysis will be as accurate and precise as the current gold standard (RSA). A subset of the patients will have RSA performed as well for direct comparison between the systems regarding migration.

A transition from plain X-ray images to low-dose CT will result in a marginal increase in the radiation dose. At the same time, it means that a much more accurate imaging of the skeleton is performed, and thus improved preoperative planning and a per-operative navigation can be done with much more predictable results. This study has been approved by the Swedish Ethical Review Authority, as well as the local radiation committee. The company, Ortoma, supplying the measurement system for planning and navigation (Ortoma Treatment Solution (OTS™)) has received ISO13485 certification and CE-certificate on all parts.

Eligibility criteria: Inclusion Criteria:

* Primary or secondary hip osteoarthritis
* Qualified for total hip arthroplasty surgery at the regional Hospital

Exclusion Criteria:

* BMI \>35
* Unable to comprehend the patient information
* Other cause for assessing the patient as ineligible (such as: serious medical comorbidity or active drug abuse)

Primary outcomes:
measure: CT validation
timeFrame: Up to 10 days after surgery
measure: Change in prosthetic migration
timeFrame: First evaluation after 1 year and planned further at 2 years after surgery
Secondary outcomes:
measure: Forgotten Joint Score (FJS)
timeFrame: Up to 2 years after surgery (preop, 3 months, 1 and 2 years)
measure: Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
timeFrame: Up to 2 years after surgery (preop, 3 months, 1 and 2 years)
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Orthopedics, Skåne University Hospital, Lund University
state: Skåne
Study officials:
affiliation: Dept of Orthpaedics, Skane University Hospital, Sweden
name: Gunnar Flivik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: