Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05159206 |
| Other study ID # |
OTS plan, nav, migr |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Region Skane |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
