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NOT YET RECRUITING
NCT06924567

Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

Sponsor: Georgios Tsikandylakis, MD PhD

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2026-09-15

Completion Date

2029-12-31

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

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,

Locations (6)

Hvidovre Hospital

Copenhagen, Denmark

Oslo University Hospital

Oslo, Norway

Sahlgrenska University Hospital

Gothenburg, Sweden

Hässleholm Hospital

Hässleholm, Sweden

Danderyd Hospital

Stockholm, Sweden

Akademiska University Hospital

Uppsala, Sweden