NCT06924567

Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

The Accuracy of CT-based Implant Movement for the Evaluation of Cup and Stem Stability, When Plain Radiography is Not Conclusive for Loosening, in Patients Scheduled for Revision Hip Arthroplasty. A Multicenter Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Georgios Tsikandylakis, MD PhD · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this validation study is to compare the preoperative implant stability, assessed by Implant Movement Analysis (IMA), provocation dual CT scans, with the intraoperative stability evaluation in revision hip arthoplasty. The main question it aims to answer is: Does IMA reflect the intraoperative clinical evaluation of implant stability? Participants scheduled for revision hip arthoplasty will undergo IMA preoperativelly in addition to rutine clinical work up. During revision arthoplasty, a surgeon blinded to the IMA results will assess clinically the stability of the hip prosthesis. IMA will be compared with the intraoperative findings to assess IMAs sensitivity and specificity

Conditions

• Loosening, Prosthesis
• Hip Arthropathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Implant motion provocation CT	Implant Movement Analysis. A low dose CT scan is performed with the hip fixed in external rotation. Then another low dose CT scan is performed with the hip fixed in internal rotation.The CT scans are then overimposed to each other and implant motion in relation to host bone is visualized,

Timeline

• Start date: 2026-09-15
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-04-11
• Last updated: 2026-03-12

Locations

6 sites across 3 countries: Denmark, Norway, Sweden

Regulatory

• FDA-regulated device study