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Clinical Trials in Sweden / NCT06924567
Starting soon Observational

Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

NCT06924567 · tracked via the Priya Life Science Sweden tracker
Sponsor
Georgios Tsikandylakis, MD PhD
Phase
Observational
Started
2026-09-15
Last updated
2026-03-12

Condition(s) studied

Loosening, ProsthesisHip Arthropathy

Investigational drug(s) / intervention(s)

Implant motion provocation CT

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,

Study 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

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06924567 on ClinicalTrials.gov ↗ ← All trials in Sweden