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ClinicalTrials.gov ID

NCT06924567

Lead Sponsor

Georgios Tsikandylakis, MD PhDOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

600Estimated

Last Update Posted

Mar 12, 2026Actual

Start Date

Sep 15, 2026Estimated

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

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

Brief 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

• Loosening, Prosthesis
• Hip Arthropathy

• Implant motion provocation CT

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria:

• Patient scheduled for revision THA due to aseptic loosening.
• One component (cup or stem) has no convincing loosening signs, based on the preoperative plain radiographs and clinical assessment by the attending surgeon.
• Radiographs not older than 8 weeks prior to surgery.

Exclusion criteria:

• Both cup and stem have been preoperatively evaluated as loose
• Instability with repeating dislocation of the THA
• Non-aseptic revision surgery, based on preoperative work up.
• The scheduled revisionsurgery is cancelled.

Observational Model

Cohort

Time Perspective

Cross-Sectional

Lead Sponsor

Georgios Tsikandylakis, MD PhDOTHER

Collaborators

Sectra AB, SwedenUNKNOWN

s.m.rohrl@medisin.uio.no+47 22 22 09 87

linda.mr.andersson@vgregion.se0046762756531

cyrus.broden@akademiska.se