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

NCT05159206 | Completed

• 1 other identifier: OTS plan, nav, migr
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Keywords

Hip Osteoarthritis; Total Hip Arthroplasty; CT templating; CT migration analysis; CT navigation

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  First evaluation after 1 year and planned further at 2 years after surgery

Secondary Outcomes (2)

• Forgotten Joint Score (FJS)

  Up to 2 years after surgery (preop, 3 months, 1 and 2 years)

• Hip dysfunction and Osteoarthritis Outcome Score (HOOS)

  Up to 2 years after surgery (preop, 3 months, 1 and 2 years)

Study Arms (1)

CT group

OTHER

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

Procedure: CT group

Interventions

CT group 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.

Also known as: RSA-follow up, CT-based Navigation

CT group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Orthopedics, Skåne University Hospital, Lund University

Lund, Skåne County, 22185, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Gunnar Flivik, MD PhD

  Dept of Orthpaedics, Skane University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of patients undergoing total hip arthroplasty with a new technique of preoperative templating, per-operative navigation and postoperative migration analysis.

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: December 16, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 15, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication
• Access Criteria: On reasonable request to the study investigators

Locations

SE (1)