Hip OsteoarthritisNCT05159206
CT-based 3D Planning, Computer Navigation and Subsequent Migration Analysis in Total Hip Arthroplasty
A study testing CT group in people with Hip Osteoarthritis, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- CT group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2021to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or secondary hip osteoarthritis
- Qualified for total hip arthroplasty surgery at the regional Hospital
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopedics, Skåne University Hospital, Lund University
Lund, Skåne County, 22185
About this study
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
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.
Read the 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
- Being tested
- CT group
- Keywords
- Hip Osteoarthritis, Total Hip Arthroplasty, CT templating, CT migration analysis, CT navigation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT groupProcedure or surgery
Also called RSA-follow up, CT-based Navigation
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.
| Study group | Role | What they receive |
|---|---|---|
| CT group | Other | CT-scan preoperatively, postoperatively and at 3 months, 1 and 2 years. Per-operative navigation based on the CT scan. Receives: Procedure: CT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT validation
To validate the Ortoma treatment solution software, the investigators will compare the preoperative CT plan (planned prosthesis size and position) to the actual achieved postoperative implant size and position as measured on postoperative CT. The investigators will also compare the per-operatively measured values during surgical navigation to the measured values on postoperative CT. The measurements include translational (mm) and rotational (degrees) differences between planned, per-operative and achieved implant position, as well as offset and leg length differences (mm).
Measured: Up to 10 days after surgery
Change in prosthetic migration
To measure migration over time (cup to pelvic bone and stem to femur bone) subsequent CT scans will be taken postoperative, at 3 months, 1 and 2 years after surgery. A subgroup of 10 patients will have RSA-follow up as well, at the same time intervalls, to compare to. The investigators will measure translational and rotational migration and if possible a 3D-vector.
Measured: First evaluation after 1 year and planned further at 2 years after surgery
Secondary outcomes (2)
Forgotten Joint Score (FJS)
Patients will be asked to fill in this patient reported outcome measure form (FJS) before, and after surgery
Measured: Up to 2 years after surgery (preop, 3 months, 1 and 2 years)
Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Patients will be asked to fill in this patient reported outcome measure form (HOOS) before, and after surgery
Measured: Up to 2 years after surgery (preop, 3 months, 1 and 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2023
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of patients undergoing total hip arthroplasty with a new technique of preoperative templating, per-operative navigation and postoperative migration analysis.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Flivik, MD PhD, Principal investigator, Dept of Orthpaedics, Skane University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159206
- Sponsor's protocol ID
- OTS plan, nav, migr
- Status last verified
- Jun 2025
- First submitted
- 26 Oct 2021
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study publication, IPD underlying the results will be available on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05159206
- Acronym / sponsor ID
- OTS plan, nav, migr
- Conditions
- Hip Osteoarthritis
- Keywords
- Hip Osteoarthritis, Total Hip Arthroplasty, CT templating, CT migration analysis, CT navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of patients undergoing total hip arthroplasty with a new technique of preoperative templating, per-operative navigation and postoperative migration analysis.
| Arm | Type | Receives |
|---|---|---|
| CT group | Other | Procedure: CT groupCT-scan preoperatively, postoperatively and at 3 months, 1 and 2 years. Per-operative navigation based on the CT scan. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary or secondary hip osteoarthritis
- Qualified for total hip arthroplasty surgery at the regional Hospital
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT groupAlso: RSA-follow up, CT-based NavigationThis 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. | Procedure or surgery | CT group |
Primary outcome
CT validation
Time frame: Up to 10 days after surgery
To validate the Ortoma treatment solution software, the investigators will compare the preoperative CT plan (planned prosthesis size and position) to the actual achieved postoperative implant size and position as measured on postoperative CT. The investigators will also compare the per-operatively measured values during surgical navigation to the measured values on postoperative CT. The measurements include translational (mm) and rotational (degrees) differences between planned, per-operative and achieved implant position, as well as offset and leg length differences (mm).
Change in prosthetic migration
Time frame: First evaluation after 1 year and planned further at 2 years after surgery
To measure migration over time (cup to pelvic bone and stem to femur bone) subsequent CT scans will be taken postoperative, at 3 months, 1 and 2 years after surgery. A subgroup of 10 patients will have RSA-follow up as well, at the same time intervalls, to compare to. The investigators will measure translational and rotational migration and if possible a 3D-vector.
2 secondary outcomes
Forgotten Joint Score (FJS)
Time frame: Up to 2 years after surgery (preop, 3 months, 1 and 2 years)
Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Time frame: Up to 2 years after surgery (preop, 3 months, 1 and 2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes. After study publication, IPD underlying the results will be available on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Flivik, MD PhD principal investigator
Dept of Orthpaedics, Skane University Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT group in people with Hip Osteoarthritis, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT validation (time frame: Up to 10 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.