CT-based 3D Planning, Computer Navigation and Subsequent Migration Analysis in Total Hip Arthroplasty

NCT ID: NCT05159206

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-12-15

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.

Conditions

Hip Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT group

CT-scan preoperatively, postoperatively and at 3 months, 1 and 2 years. Per-operative navigation based on the CT scan.

Group Type: OTHER

CT group

Intervention Type: PROCEDURE

This group will do a preoperative CT scan for templating. The same scan is then used for per-operative navigation. After surgery, a postoperative CT will validate the templating/navigation, and then subsequent CT scans (postoperative, 3 months, 1 and 2 years) will be done to measure prosthetic migration over time.

Interventions

CT group

This group will do a preoperative CT scan for templating. The same scan is then used for per-operative navigation. After surgery, a postoperative CT will validate the templating/navigation, and then subsequent CT scans (postoperative, 3 months, 1 and 2 years) will be done to measure prosthetic migration over time.

Intervention Type: PROCEDURE

Other Intervention Names

RSA-follow up; CT-based Navigation

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunnar Flivik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Orthpaedics, Skane University Hospital, Sweden

Locations

Department of Orthopedics, Skåne University Hospital, Lund University

Lund, Skåne County, Sweden

Countries

Sweden

Other Identifiers

OTS plan, nav, migr

Identifier Type: -

Identifier Source: org_study_id